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Glen Justice, MD CV (Abridged)
- 1. 1 Glen Robert Justice, M.D. __________________________________________________________________ PERSONAL INFORMATION Cell Phone: (949)-636-9663 Email: grjusticemd@gmail.com Date of Birth: December 13, 1944 Place of Birth: Ironton, Ohio Citizenship: USA LICENSURE • California Medical License #G23862 BOARD CERTIFICATIONS • Board Certified, Oncology • Board Certified, Internal Medicine PROFESSIONAL EXPERIENCE 1987 – Present Professor of Medicine University of Southern California Los Angeles, California 2013 – Present Director of Hematology/Oncology Lestonnac Free Clinic, an organization of 13 clinics comprising California’s largest free clinic; multiple humanitarian medical trips, including those to Cambodia, Haiti, Mexico, Vietnam, Shri Lanka, Ukraine, etc. 2013 – Present Medical Director Mary’s Free Kitchen, a monthly free clinic providing treatment to the homeless/indigent population Orange, CA 2017 – Present Co-Founder & Clinical Director/Principal Investigator Odyssey Clinical Research LLC, a philanthropic organization providing advanced treatment to neglected minority and uninsured populations Orange, CA 2000 – 04/2010 Member, Division Board of Directors American Cancer Society California 2005 – 04/2010 Medical Director of Oncology Services Orange Coast Memorial Medical Center Fountain Valley, California 1999 – 04/2010 President, American Cancer Society Orange County Division California 1979 – 04/2010 Founder & President/CEO
- 2. 2 Pacific Coast Hematology/Oncology Medical Group, Inc. Fountain Valley, California 1990 – 03/2006 Member, Hospital Board of Directors Fountain Valley Regional Hospital and Medical Center Fountain Valley, California 1997 – 2004 Chairman, Hospital Board of Directors Fountain Valley Regional Hospital and Medical Center Fountain Valley, California 1995 – 2005 Medical Director Orange County Regional Cancer Center Affiliated with USC/Norris Comprehensive Cancer Center Fountain Valley, California 1981 – 2000 Principal Investigator Southwest Oncology Group (SWOG), a cooperative research study group comprised of 4,000 members representing 650 institutions 1995 – 1997 Vice Chairman, Hospital Board of Directors Fountain Valley Regional Hospital and Medical Center Fountain Valley, California 1994 – 1999 Board of Directors American Cancer Society Orange County Division 1992 – 1994 Medical Director, Oncology Program Western Medical Center Santa Ana, California 1987 – 1992 Associate Clinical Professor of Medicine University of California, Los Angeles Los Angeles, California 1974 – 1991 Principal Investigator & Member National Surgical Adjuvant Breast and Bowel Project (NSABP) 1986 – 1987 Chief of Oncology St. Mary’s Medical Center Long Beach, California 1976 – 1978 Assistant Professor of Medicine University of California, San Francisco San Francisco, California 1976 – 1978 Director, Granulocyte Support and Cell Separator Unit Letterman Army Medical Center San Francisco, California 1976 – 1977 Chief, Hematology/Oncology Service Letterman Army Medical Center San Francisco, California 1976 – 1977 Director, Hematology/Oncology Fellowship Program
- 3. 3 Letterman Army Medical Center San Francisco, California 1973 – 1975 Co-Founder & Member Western Study Cancer Group, a cooperative venture between several prominent Northern California universities and San Francisco-based hospitals HOSPITAL AFFILIATIONS • Fountain Valley Regional Hospital and Medical Center Fountain Valley, California • Garden Grove Hospital Garden Grove, California • Hoag Memorial Hospital Presbyterian Newport Beach, California • Irvine Medical Center Irvine, California • Orange Coast Memorial Medical Center Fountain Valley, California • Los Angeles County/USC Medical Center Los Angeles, California • USC/Norris Comprehensive Cancer Center Los Angeles, California • Western Medical Center Santa Ana, California EDUCATION AND TRAINING 1973 – 1975 Hematology/Oncology Fellowship Letterman Army Medical Center San Francisco, California Experience & Awards ▪ Joyce Keyon Research Award for Outstanding Scientific Research, 1975 ▪ Granulocyte Cell Culture Research with Dr. Donald Metcalf at Walter at the Walter and Eliza Cancer Institute, Melbourne, Australia ▪ Rotation with Dr. S. Spivack at the California Research Institute at the University of California, San Francisco ▪ Rotation with Dr. R. Waterstein at the California Research Institute at University of California, San Francisco ▪ Clinical Investigator, Western Study Cancer Group ▪ Research Study Manager, Western Study Cancer Group 1970 – 1973 Internal Medicine Internship & Residency Letterman Army Medical Center 1 ½ years at University of California, San Francisco and Stanford University San Francisco, California & Palo Alto, California
- 4. 4 Experience & Awards ▪ Resident of the Year, 1972 ▪ Teaching Resident of the Year ▪ Granulocyte Cell Culture Research with Dr. Wm Robinson ▪ Tropical Medicine Course at Walter Reed Medical Center 1966 – 1970 Medical Degree University of Southern California Los Angeles, California Experience & Awards ▪ Alpha Omega Alpha ▪ Honors in Medicine & Surgery 1970 ▪ Research Assistant to Drs Robert Peters & Hugh Edmonson on Collagen and Hydroxyproline in Cirrhosis, 1966 – 1968 1964 – 1966 Bachelor of Science University of Southern California Los Angeles, California Experience & Awards ▪ Graduated Magna Cum Laude ▪ Phi Beta Kappa ▪ Phi Kappa Phi (Honorary Science Fraternity) ▪ History Honor Society ▪ Dean’s List (4 years) ▪ Pre-Medical Student of the Year, 1964 ▪ Research Assistant to Dr. R. Gunn on Encephalitis, 1963 MEMBERSHIPS AND SOCIETIES • Phi Beta Kappa • Alpha Omega Alpha • American Medical Association • American Society of Clinical Oncology • California Medical Association • Medical Oncology Association of Southern California CLINICAL RESEARCH AFFILIATIONS • Member, Southwest Oncology Group • Member, Breast Cancer International Research Group • Member, National Surgical Adjuvant Breast and Bowel Project • Member, Breast Cancer International Research Group • Member, Gynecologic Oncology Group PUBLICATIONS AND PRESENTATIONS • Over 1,500 hematologic/oncologic clinical study publications in academic and scholarly research journals • Over 500 miscellaneous medical presentations to universities, pharmaceutical companies, physicians, and community • Extensive television, radio, and newspaper interviews PUBLICATIONS
- 5. 5 • Toxic Alopecia from Ingestion of Boric Acid. Arch Derm, July 1973. • Abnormal Colony Stimulating Activity in Polycythemia Vera – A Discriminant between Primary and Secondary Polycythemias. American Society of Hematology, 1974. • The Effect of Oxymethalone on Granulopoiesis as Reflected by CFU in a MOPP Treatment Patient. Proc Amer Acad of Clin Res, 1974. • Methotrexate with Leucovorin Rescue in the Treatment of Gynecologic Malignancies: A Preliminary Report. Oncology, v32, 1975. • Clinical Applications of Cell Culture in Evaluation of Granulopoiesis. Present Concepts, Hematology Symposium, 1975. • Neutrophil Transfusions in Febrile Neutropenic Patients: A Community Approach with Increased Patient Survival Independent of Lymphocyte Cytotoxicity Crossmatch. Presented and Published, Amer Soc of Hem, 1975. • Effect of Calcium Leucovorin in Reduction of Serious Infections in Patients Treated with Combination Chemotherapy for Metastatic Breast Cancer. Clin Research, October 1975. • Successful Therapy with Methotrexate of a Multicentric Mixed Lymphoma of the Central Nervous System. Cancer, v38, 1976. • Regional Support of Neutropenic Patients with Granulocyte Transfusions. Proc of Air Force Regional ACP Meeting, February 1978. • Neutrophil Transfusions in Febrile Neutropenic Patients: Decreased Effectiveness with Certain Blood Culture Results. Amer Soc Hem, March 1978. • General Concepts of Cancer Chemotherapy for the Internist. Present Concept, Symposium of Hematology, March 1978. • Overview of Aggressive Combination Chemotherapy in Oat Cell Carcinoma of the Lung: A Letterman Army Center Experience, Cancer, August 1979. • Cancer Chemotherapy for Family Doctors. Patient Care, May 15, 1979. • Decision Making in Cancer Chemotherapy. Patient Care, October 15, 1979. • A Large Experience with Granulocyte Transfusion. New Eng J Med, July 1981. • Ring-Shaped Particles as a Cancer Marker for Discriminating between Malignant and Nonmalignant Disease. Amer Soc Clin Onc, May 1991. • The Ring-Shaped Particle as a Cancer Marker for Discriminating between Malignancy and Nonmalignancy: A Pantumor Marker. J Clin Onc, May 1992. • Textbook – Cancer Chemotherapy for General Physicians. Saunders, 1990. • Book – Comprehensive Breast Cancer and Surviving Breast Cancer. Berman, 2000. • Updated Results of a Phase II Study of Trimetrexate (Neutrexin), 5-Fluorouracil and Leucovorin (NFL) in Advanced Pancreatic. Amer Soc Clin Onc, May 2001. • Evaluation of Docetaxel and Cisplatin with Filgrastim Support for the Treatment of Patients with Stage III or IV Non-Small Cell Lung Cancer. Amer Soc Clin Onc, May 2001. • A Dose-Finding and Safety Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anemia in Patients Receiving Multicycle Chemotherapy. Amer Soc Clin Onc, May 2001. • Breast Cancer Risk Assessment (RA) and Prevention Education: Changing Perceptions of and Emotional Responses to Risk in a Community Center for Breast Care. Amer Soc Clin Onc, May 2001. • Starving the Tumor: CURE, Cancer Updates, Research & Education. Spring 2002. • Lead author of 3 articles on Second Generation Growth Factors for Aranesp with Amgen Pharmaceuticals. Presented in Lugano, Italy; Nice, France; Rome, Italy. Second half of 2002. • Oncoscience Marker 222 Monoclonal Antibody – Pantumor Marker in Phase III Study of Stage IV Lung Cancer and Stage IV Breast Cancer is Highly Accurate and Specific in Detecting the Presence of Metastatic Disease. Amer Soc of Clin Onc, May 2003. • Results of a Randomized Study of Every Three-Week Dosing (Q3W) of Darbepoetin Alfa for Chemotherapy- Induced Anemia (CIA). ASH, August 2003. • Epoetin Alfa 40,000 U QW vs Darbepoetin Alfa 200 mcg Q2W in Anemic Cancer Patients Receiving Chemotherapy: Preliminary Results of a Comparative Trial. ASCO. June 2004. • Capecitabine (X) Plus Irinotecan (XELIRI) as First-Line Treatment for Metastatic Colorectal Cancer (MCRC): Final Safety Findings from a Phase II Trial. ASCO. June 2004.
- 6. 6 • Results of a Randomized Study of Every Three-Week Dosing (Q3W) of Darbepoetin Alfa for Chemotherapy- Induced Anemia (CIA). ASCO. June 2004. • Randomized Study of Darbepoetin Alfa Administered Subcutaneously or Intravenously in Patients with Chemotherapy-Induced Anemia (CIA). MASCC. 2004. • A Randomized, Open-label Multicenter Trial of Early Versus Late Intervention with Darbepoetin Alfa for Chemotherapy-Induced Anemia. Pending. • Randomized Comparison of Epoetin Alfa (40,000 U Weekly) and Darbepoetin Alfa (200 ug Every 2 Weeks) in Anemic Patients with Cancer Receiving Chemotherapy. The Oncologist 2005; 10: 642-650. • A Randomized, Multicenter Study of Subcutaneous and Intravenous Darbepoetin Alfa for the Treatment of Chemotherapy-Induced Anemia. Annals of Oncology 16: 1192-1198, 2005. • Capecitabine Plus 3-Weekly Irinotecan (XELIRI Regimen) as First-Line Chemotherapy for Metastatic Colorectal Cancer Phase II Trial Results. Cancer: A Journal of American Cancer Society, 2006. • Weekly Epoetin Alfa Treatment of Anemia in Patients with Cancer Not Undergoing Therapy. The Journal of Supportive Oncology, Volume 4, Number 3. March 2006. • Preliminary Results from a Phase II Study of Lenalidomide Monotherapy in Relapsed/Refractory Aggressive Non-Hodgkin’s Lymphoma, ASH Journal, 2006. • A Randomized, Open-Label, Multicenter trial of Immediate (On-Time) versus Late Intervention with Darbepoetin Alfa for Chemotherapy-Induced Anemia. Oncologist, 2006. • Early Results from a Phase II Study of Lenalidomide Monotherapy in Relapses/Refractory Indolent Non- Hodgkin’s Lymphoma. Presented at the Annual American Society of Hematology, 2006. • Pancreatic Cancer: Emerging Role of Chemotherapy; and Helping Relieve Pain. Oncology Times, Volume XXVIII No. 23 / December 10, 2006. • Results from a Phase II Study of Lenalidomide Oral Monotherapy in Relapsed/Refractory Indolent Non- Hodgkin’s Lymphoma, ASH Annual Abstracts, Abstract 2560, 2007 • Lenalidomide Oral Monotherapy Produces a 53% Response Rate in Patients with Relapsed/Refractory Mantle- Cell Non-Hodgkin’s Lymphoma, ASH Annual Abstracts, Abstract 2563, 2007 • Lenalidomide Response in Relapsed/Refractory Diffuse Large B-Cell Non-Hodgkin’s Lymphoma, ASH Annual Abstracts, Abstract 2564, 2007 • Lenalidomide Response in Relapsed/Refractory Aggressive Non-Hodgkin’s Lymphoma Is Related to Tumor Burden and Time from Rituximab Treatment, ASH Annual Abstracts, Abstract 2565, 2007 • High Response Rate to Lenalidomide in Relapsed/Refractory Aggressive Non-Hodgkin’s Lymphoma with Prior Stem Cell Transplant, ASH Annual Abstracts, Abstracts 2570, 2007 • Lenalidomide Oral Monotherapy Produces Durable Responses in Relapsed- or Refractory-Indolent Non- Hodgkin’s Lymphoma: Final results of NHL-001, ASCO Abstract, 2009 INTERVIEWS • Prostate Vaccine television interview aired on KCAL-TV, Channel 9, 2006. • Raloxifene radio interview of FKI AM News Radio, April 17, 2006. • Prostate Cancer Vaccine radio interview on KFI AM New Radio, May 4, 2006. • Chemotherapy radio interview on KFI AM New Radio, June 13, 2006. • Blood Test for Lung Cancer radio interview on KFI AM New Radio, September 1, 2006. • “Good News in Battle Against Cancer”, newspaper article interview, Los Angeles Times, January 17, 2007. • “The End: Fact, fiction and a little happy talk”, newspaper article interview, Orange County Register, March 3, 2007. • The use of Avastin for brain cancer radio interview on KFI-AM 640, February 25, 2007. • “Breath tests detects most cases of lung cancer” radio interview on KFI-AM 640, March 7, 2007. • “Computed Tomography Screening May Increase Rate of Lung Cancer Diagnosis, But Not Decrease Risk of Death”, newspaper article interview, Los Angeles Times, March 7, 2007. • “John McCain’s skin cancers were deadliest kind”, Newspaper Interview, Los Angeles Times, By Thomas H. Maugh II, May 24, 2008. • “Marijuana, testicular cancer link is found”, Newspaper Article Interview, Los Angeles Times, By Mary Engel, February 16, 2009.
- 7. 7 • “Prostate cancer screenings provide little benefit, studies show”, Newspaper Article, Los Angeles Times, By Thomas H. Maugh II, March 18, 2009. CLINICAL RESEARCH ACITVITY • A Randomized, Phase III Study of Gemcitabine Plus Cisplatin versus MVAC Chemotherapy in Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium, Principal Investigator • A Therapeutic Evaluation of a Two Drug Combination of Doxorubicin Plus Vinorelbine, Administered on Days 1 and 4 of a 21-Day Cycle as Front-Line Therapy in Patients with Advanced Metastatic Breast Cancer, Principal Investigator • A Clinical Study of Intravenous Navelbine in Combination with Intravenous Doxorubicin or 5-Fluorouracil as First-Line Treatment of Patients with Advanced Breast Cancer, Principal Investigator • A Clinical Trial to Determine the Worth of Tamoxifen for Preventing Breast Cancer, Principal Investigator • A Clinical Trial to Evaluate the Worth of Tamoxifen in Conjunction with Lumpectomy and Breast Irradiation for the Treatment of Non-Invasive Intraductal Carcinoma (DCIS) of the Breast, Principal Investigator • A Clinical Trial to Evaluate the Effect of Dose Intensification and Increased Cumulative Dose of Post- Operative Adriamycin/Cyclophosphamide (AC) Therapy with G-CSF on the Disease-Free Survival and Survival of Patients with Primary Breast Cancer and Positive Axillary Nodes, Principal Investigator • Phase III Comparison of Combination Chemotherapy (CAF and Chemo-Hormonal Therapy) in Premenopausal Women with Axillary Node-Positive Receptor-Positive Breast Cancer, Principal Investigator • Adjuvant Treatment of High-Risk Resectable Carcinomas of the Breast: Eight Week Induction Chemotherapy with Adriamycin/5-Fluorouracil + Methotrexate + Leucovorin Followed by Mobilization of Peripheral Blood Stem Cells with High-Dose Cyclophosphamide + VP15 and CGSF Followed by Triple Alkylator Dose- Intensification with Peripheral Blood Stem Cell Rescue, Sub-Investigator • Comparison of CGS-16949A versus Megestrol Acetate in Postmenopausal Women with Breast Carcinoma, Principal Investigator • Daunoxome for the Treatment of Metastatic Breast Cancer, Principal Investigator • A Comparative Trial of Droloxifene and Tamoxifen as First-Line Hormonal Therapy in Women with Advanced Breast Cancer, Principal Investigator • Comparison of Two Doses (0.5 mg and 2.5 mg) or Letrozole (CGS 20267) versus Megestrol Acetate in Postmenopausal Women with Advanced Breast Cancer, Principal Investigator • Comparative Trial of Aredia versus Placebo for Prevention of Skeletal-Related Complications in Patients with Breast Cancer and Lytic Bone Lesions Treated with Chemotherapy, Principal Investigator • Comparative Trial of Aredia versus Placebo for the Prevention of Skeletal-Related Complications in Patients with Breast Cancer and Lytic Bone Lesions Treated with Hormonal Therapy, Principal Investigator • Phase II, Open-Label, Multicenter Study of Single Agent Doxil in the Treatment of Patients with Arthracycline Resistant, Locally Advanced, or Metastatic Cancer, Principal Investigator • Assessment of the Predictive Value of the Extreme Drug Resistance (EDR) Assay in Patients Receiving Paclitaxel for Metastatic Breast Cancer, Principal Investigator • A Randomized, Double-Blind Trial Comparing Arimidex Alone with Nolvadex Alone with Arimidex and Nolvadex in Combination as Adjuvant Treatment in Postmenopausal Women with Breast Cancer, Principal Investigator • Comparison of the Effect of SCH 57050 and Anastrazole in Subjects with Breast Cancer Relapsing After an Initial Response to Tamoxifen or Showing Progression After Tamoxifen Given as Adjuvant to Surgery: A Prospective, Double-Blind, Phase III Trial, Principal Investigator • Daunoxome as First-Line Therapy for the Treatment of Metastatic Breast Cancer, Principal Investigator • Adriamycin/Cytoxan Followed by Taxol or Taxotere Either Weekly or Every Three Weeks for Women with Stage IIa, IIb, or IIIa Breast Cancer with Six Lymph Nodes Removed, Principal Investigator • Medroxyprogesterone Acetate Plus Tamoxifen in Postmenopausal Women with Breast Cancer (T1-3 N0-1 M0), Principal Investigator • A Multicenter, Open-Label, Randomized Study of Three Schedules of Weekly Taxol Induction Therapy Followed by Weekly Taxol Maintenance Therapy in Metastatic Breast Cancer Patients, Sub-Investigator • A Phase II, Randomized Trial of Gemcitabine Plus Taxol versus Taxol in Patients with Metastatic Breast Cancer Who Have Failed Anthracylines, Principal Investigator
- 8. 8 • Phase III Trial of Taxol/Doxorubicin (Two Dose Levels) versus Doxorubicin/Cytoxan Followed by a Comparison of Weekly versus Q3 Weekly Taxol in Patients with Metastatic Breast Cancer, Sub-Investigator • Phase II Evaluation of the Optimal Schedule of SC-70935 in Patients with Breast Cancer Receiving Chemotherapy with Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), Principal Investigator • A Double-Blind, Randomized, Multicenter Trial Comparing the Efficacy and Tolerability of 125 mg and 250 mg of Faslodex with 20 mg of Nolvadex in Postmenopausal Women with Advanced Breast Cancer, Principal Investigator • A Double-Blind, Randomized Multicenter Trial Comparing the Efficacy and Tolerability of 125 mg and 250 mg of Faslodex with 20 mg of Nolvadex in Postmenopausal Women with Advanced Breast Cancer, Principal Investigator • Radiation Plus Cisplatin versus Radiation Plus 5-Fluorouracil Infusion Protracted in the Treatment of Stages IIb, IIIb and IV Cervical Cancer, Sub-Investigator • A Clinical Trial to Assess the Relative Efficacy of 5-Fluorouracil + Leucovorin with or without Interferon Alpha-2a in Patients with Dukes’ B and C Carcinoma of the Colon, Principal Investigator • A Clinical Trial to Evaluate the Worth of Preoperative Multimodality Therapy 95-Fluorouracil/Leucovorin and Radiation Therapy) in Patients with Operable Carcinoma of the Rectum, Principal Investigator • A Phase II Trial of Trimetrexate, 5-Fluorouracil and Leucovorin in Previously Treated Patients with Unresectable or Metastatic Colorectal Cancer, Principal Investigator • Therapeutic and Biological Effects of the Bi-Specific Antibody MDX-H210 Combined with GM-CSF in Patients with Her2/neu Positive Advanced Colorectal Carcinoma, Principal Investigator • A Prospective, Randomized, Multicenter Phase III Clinical Trial Comparing the Effects of Panorex Injection Plus 5-Fluorouracil-Based Chemotherapy versus 5-Fluorouracil-Based Chemotherapy Alone in Patients with Surgically Resected Stage III Carcinoma of the Colon, Principal Investigator • A Double-Blind, Placebo-Controlled, Randomized Phase III Trial of 5-Fluorouracil and Leucovorin + Neutrexin in Previously Untreated Patients with Advanced Colorectal Cancer, Principal Investigator • A Phase II Study to Determine the Biological Effects of Bi-Specific Antibody MDX-H210 Combined with GM- CSF in Patients with Advanced Prostate Cancer or Renal Cell Carcinomas that Express HER2/neu, Principal Investigator • A Compassionate Use Study of Oxaliplatin in the Treatment of Metastatic Colorectal Carcinoma, Principal Investigator • A Multicenter Study Evaluating the Addition of Oxaliplatin to 5-Fluorouracil-Based Chemotherapy in Subjects with Refractory Colorectal Cancer, Sub-Investigator • A Phase II, Randomized, Multicenter Comparison of the Efficacy of Oxaliplatin in Four Schedules of 5- Fluorouracil with and without Leucovorin in Previously Untreated Advanced Colorectal Cancer, Principal Investigator • A Randomized, Open-Label, Multicenter Phase III Study of 5-Fluorouracil/Leucovorin with or without Concomitant SU-5416 in Patients with Metastatic Colorectal Cancer, Principal Investigator • Cisplatin Plus Doxorubicin or Cisplatin Plus Doxorubicin Plus Taxol with GCSF Support in the Treatment of Stage III-IV Primary or Recurrent Endometrial Cancer, Sub-Investigator • Estrogen Replacement Therapy versus Placebo in the Treatment of Stage I-II Endometrial Adenocarcinoma, Sub-Investigator • Open-Label, Randomized, Multicenter Phase II/III study of Docetaxel in Combination with Cisplatin (CDDP)or Docetaxel in Combination with 5-Fluorouracil and CDDP Compared to the Combination of CDDP and 5- Fluorouracil in Patients with Metastatic or Locally Recurrent Gastric Cancer Previously Untreated with Chemotherapy for Advanced Disease, Sub-Investigator • Phase III Study of Radiation Therapy + Amifostine in Patients with Head and Neck Cancer, Sub-Investigator • A Phase III Comparison of Fludarabine Phosphate versus Chlorambucil versus Fludarabine Phosphate and Chlorambucil in Previously Untreated B-cell Chronic Lymphocytic Leukemia, Principal Investigator • A Phase II Evaluation of Taxol in Patients with Relapsed Non-Hodgkin’s Lymphoma or Relapsed Hodgkin’s Disease, Principal Investigator • Daunoxome and Dexamethasone Therapy with GM-CSF Support for Patients with Multiple Myeloma: A Phase II International Study Oncology Group (ISOG) Protocol, Principal Investigator • Comparative Trial of Aredia versus Placebo for the Prevention of Skeletal-Related Complications in Patients with Multiple Myeloma and Lytic Bone Lesions Treated with Chemotherapy, Principal Investigator
- 9. 9 • Phase II Study of High-Dose Melphalan with Hematopoietic Stem Cell Support and GM-CSF in Refractory Multiple Myeloma, Sub-Investigator • Sequential High-dose Cyclophosphamide and High-Dose BCNU/Etoposide/Melphalan Followed by Hematopoietic Rescue in Patients with Multiple Myeloma, Sub-Investigator • High-Dose Chemotherapy and Hematopoietic Stem Cell Rescue as Consolidation Therapy During First Complete or Partial Remission in Patients with Poor Risk Aggressive Lymphoma, Sub-Investigator • High-Dose Etoposide, Cyclophosphamide, and either Fractionated Total Body Irradiation or Carmustine with Autologous Bone Marrow Rescue for Refractory or Relapsed Hodgkin’s Disease, Sub-Investigator • Sequential High-dose Cyclophosphamide and High-Dose BCNU/Etoposide/Melphalan Followed by Hematopoietic Rescue in Patients with Lymphoma in “Sensitive” Relapse, Sub-Investigator • Daunoxome as First-Line Treatment of Non-Hodgkin’s Lymphoma, Principal Investigator • Phase II Study of Doxil in the Treatment of Patients with Relapsed or Refractory Low and Intermediate Grade Non-Hodgkin’s Lymphoma, Principal Investigator • Treatment of Rituxan/ESHAP for Intermediate-High Grade Non-Hodgkin’s Lymphoma, Principal Investigator • Rituximab Anti-CD20 Monoclonal Antibody Plus Oral Cyclophosphamide as Initial Treatment of Indolent Lymphoma, Principal Investigator • ABVD Radiation Therapy versus Stanford Radiation Therapy for Patients with Stage I-IIa/b or Advanced State III-IV Hodgkin’s Lymphoma, Principal Investigator • A Phase II Study of Cisplatin Preceded by a 12-hour Continuous Infusion of Concurrent Hydroxyurea and Cytosine Arabinoside (ARA-C) for Patients with Untreated Malignant Mesothelioma, Principal Investigator • A Blinded Clinical Trial Utilizing the Ring-Shaped Particle as a Tumor Marker for Lung Cancer, Principal Investigator • Phase III Trial of Gemcitabine Plus Cisplatin versus Cisplatin Alone in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer, Principal Investigator • An Open-Label, Multicenter, Non-Comparative Study of Topotecan as Single Agent, Second-Line Therapy in Patients with Small Cell Lung Cancer, Sub-Investigator • Evaluation of Doxetaxel and Cisplatin with Filgrastim Support for the Treatment of Patients with Stage III or IV Non-Small Cell Lung Cancer, Sub-Investigator • Randomized Trial of Surgery versus Chemotherapy Followed by Surgery for Stage Ib, IIa, IIIa Lung Cancer, Principal Investigator • A Multicenter, Randomized, Phase II Trial of Weekly Docetaxel + Gemcitabine versus Weekly Paclitaxel + Gemcitabine in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer, Principal Investigator • A Phase IV, Open-Label, Prospective, Randomized, Multicenter Trial Comparing the Quality of Life in Elderly Subjects Receiving either Navelbine Injection, as a Single Agent, or Best Supportive Care for the Treatment of Previously Untreated, Stage IV Non-Small Cell Lung Cancer, Principal Investigator • An Open-Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan versus Intravenous Topotecan for Second-Line Therapy in Patients with Small Cell Lung Cancer Who Have Relapsed Greater than or Equal to 90 Days After Completion of First-Line Therapy, Sub-Investigator • A Phase III, Randomized Study of Intravenous Cisplatin and Cyclophosphamide versus Intravenous Cisplatin and Taxol versus High-Dose Intravenous Carboplatin Followed by Intravenous Taxol and Intraperitoneal Cisplatin in Patients with Optimal Stage III Epithelial Ovarian Carcinoma, Sub-Investigator • Open-Label, Multicenter, Randomized Phase III Study of Topotecan as Single Agent, Second-Line Therapy versus Taxol in Women with Advanced Epithelial Ovarian Carcinoma, Sub-Investigator • Topotecan and Cisplatin in the Treatment of Stage III-IV Ovarian Cancer, Sub-Investigator • Modulation of 5-Fluorouracil with Trimetrexate and Leucovorin in Advanced Pancreatic Cancer, Sub- Investigator • Phase III Randomized Study of RFS 2000 versus Gemcitabine HCI in Chemo-Naïve Pancreatic Cancer Patients, Sub-Investigator • Phase III Randomized Study of RFS 2000 versus 5-Fluorouracil in Pancreatic Cancer Patients that Have Progressive Disease Following Gemcitabine HCI Treatment, Sub-Investigator • Phase III Study of RFS 2000 versus Most Appropriate Chemotherapy in Refractory Pancreatic Cancer Patients, Sub-Investigator • Treatment of Stage D, Hormone Refractory Carcinoma of the Prostate with 5-Fluorouracil and Roferon-A, Phase II, Principal Investigator
- 10. 10 • A Phase II Trial of Antiandrogen Withdrawal in Patients with Progressive Prostate Cancer, Principal Investigator • A Phase III Trial of Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Principal Investigator • Phase II Trial of Docetaxel and Epirubicin in Patients with Hormone Refractory Prostate Cancer, Principal Investigator • A Phase II Trial to Determine the Biological Effects of Bi-Specific Antibody MDX-H210 Combined with GM- CSF in Patients with Advanced Prostate Cancer or Renal Cell Carcinomas with Express HER2/neu, Principal Investigator • Interleukin 2 in an Alternative Dose: Treatment of Patients with Metastatic Renal Cell Cancer with Low Dose Proleukin, Principal Investigator • A Randomized Trial of Adjuvant Immunotherapy with an Allogenic Melanoma Vaccine for Patients with Intermediate Thickness, Node Negative Malignant Melanoma (T3N0M0), Phase III, Principal Investigator • Postoperative Adjuvant Interferon Alpha 2 in Resected High-Risk Primary and Regionally Metastatic Melanoma, Principal Investigator • Prospective Quality of Life Evaluation During Megestrol Acetate Treatment for Anorexia/Cachexia, Principal Investigator • Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Oral Ondansetron in the Control of Delayed Emesis and Nausea Induced by Cisplatin, Principal Investigator • A Double-Blind, Parallel, Multicenter Study Comparing the Efficacy and Safety of Intravenous Granisetron and Ondansetron in the Prophylaxis of Nausea and Emesis Induced by Cisplatin-based Chemotherapy, Principal Investigator • A Phase IV Clinical Evaluation of Procrit in Anemic Cancer Patients receiving Chemotherapy, Principal Investigator • A Double-Blind, Parallel, Multicenter Study in Patients with Malignant Disease Who Receive Intravenous Granisetron 10 mcg/kg or 40 mcg/kg to Control Nausea and Vomiting During Multiple Cycles of Highly Emetogenic, Cisplatin Based Chemotherapy, Principal Investigator • Mechanisms of Action of Megestrol Acetate in Cancer Malnutrition, Principal Investigator • A Double-Blind, Multicenter, Crossover Study Comparing the Efficacy and Safety of Intravenous Ondansetron Hydrochloride 32 mg in the Prevention of Nausea and Vomiting Induced by the Intravenous Cyclophosphamide and Doxorubicin Chemotherapy in Patients with Breast Cancer, Principal Investigator • A Randomized, Double-Blind Comparison of the Single-Dose Ondansetron Intravenous versus Single-Dose Intravenous Granisetron on the Prevention of Nausea and Vomiting with High-Dose Cisplatin Chemotherapy, Principal Investigator • A Stratified, Randomized, Double-Blind Comparison of Oral Ondansetron and Compazine Spansules for the Prevention of Nausea and Vomiting Associated with Moderately-Emetogenic Chemotherapy, Principal Investigator • An Open-Label, Uncontrolled, Multicenter Study to Evaluate the Efficacy and Safety of Two 1 mg Tablets of Kytril Given Once Prior to Chemotherapy in the Prevention of Nausea and Vomiting Induced by Cisplatin- Based Chemotherapy, Principal Investigator • A Double-blind, Parallel, Multicenter Study Comparing the Efficacy and Safety of Intravenous Granisetron and Ondansetron in the Prophylaxis of Nausea and Emesis Induced by Cisplatin-based Chemotherapy, Principal Investigator • A Double-Blind, Multicenter, Parallel Study, Comparing the Efficacy and Safety of Oral Granisetron Hydrochloride 2 mg with Intravenous Ondansetron Hydrochloride 32 mg, Given Once, Prior to Chemotherapy in the Prevention of Nausea and Vomiting Induced by Cisplatin-Based Chemotherapy, Principal Investigator • Randomized, Double-Blind, Acyclovir-Controlled, Multicenter Study to Assess the Safety, Efficacy and Pharmacokinetics of Intravenous Pencyclovir for the Treatment of Mucocutaneous Herpes Simples Infection in Immunocompromised Patients, Principal Investigator • Phase III, Double-Masked, Randomized Study of Recombinant Human Interleukin 11 Once Daily for 14 days vs Placebo in Adult Cancer Patients with Severe Thrombocytopenia Due to Chemotherapy, Principal Investigator • A Repeated Dose Evaluation of Analgesic Use and Safety of Dilaudid SR in Patients with Chronic Non- Malignant Pain, Principal Investigator
- 11. 11 • A Repeated Dose Evaluation of Analgesic Use and Safety of Dilaudid SR in Patients with Chronic Cancer Pain, Principal Investigator • Safety and Tolerability of Long-Term Administration of Dilaudid SR, Principal Investigator • Phase II Multicenter, Double-Blind, Randomized, Placebo-Controlled, Multi-Regimen Study of CJ11,974 for the Control of Carboplatin or Doxorubicin-Induced Emesis, Principal Investigator • A Double-Blind, Multicenter, Parallel Study Comparing the Efficacy and Safety of Oral Granisetron HCI with Placebo, in the Prevention of Nausea and Vomiting During the Days Following Administration of IV Cyclophosphamide-Based or Carboplatin-Based Chemotherapy in Patients with Malignant Disease, Principal Investigator • A Randomized, Double-Blind, Placebo-Controlled Comparison of the Analgesic Activity of Valdecoxib 40 mg BID as Add-On Therapy to Opioid Medication in Patients with Chronic Cancer Pain, Sub-Investigator • A Randomized, Dose-Finding Study of Novel Erythropoiesis Stimulating Protein (NESP) Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects with Solid Tumors Receiving Multicycle Chemotherapy, Principal Investigator • A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Fragmin (5,000 IU Subcutaneously) in Preventing Catheter Related Complications when Given Daily to Cancer Patients with Central Venous Catheters, Sub-Investigator • A Phase I Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Biologic Effects of Bi- Specific Antibody MDX-H210 Combined with GCSF in Patients with Metastatic Cancer that Overexpresses HER2/neu, Principal Investigator • A Phase I/II Antibody MDX-H210 Combined with GM-CSF in Patients with Metastatic Cancer that Overexpresses HER2/neu, Principal Investigator • Acorn, A Multicenter, Randomized. Phase II Trial of Weekly Docetaxel + Gemcitabine versus Weekly Paclitaxel + Gemcitabine in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer, Sub- Investigator • Amgen, A Dose- and Schedule-Finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anemia in Subjects with Solid Tumors Receiving Chemotherapy, Principal Investigator • Amgen, A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegfilgrastim on the Incidence of Febrile Neutropenia in Subjects with Advanced Breast Cancer Treated with Single Agent Docetaxel, Principal Investigator • Amgen, A Randomized, Open-Label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects with Non-Myeloid Malignancies Receiving Multicycle Chemotherapy, Principal Investigator • Amgen, A Randomized, Open-Label, Multicenter Study of Primary Prophylaxis with Neulasta (Pegfilgrastim) versus Secondary Prophylaxis as an Adjunct to Chemotherapy in Elderly Subjects (65 y.o.) with Cancer, Principal Investigator • Amgen, An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Female Breast Cancer Patients Treated with Darbepoetin alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy, Principal Investigator • Amgen, An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients with Non-Small Cell Lung Cancer Treated with Darbepoetin alfa and Recombinant Human Erythropoietin for Anemia Due to Chemotherapy, Principal Investigator • Amgen, An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients with Gynecological Malignancies Treated with Darbepoetin alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy, Principal Investigator • Amgen, A Randomized, Open-Label, Pilot Study to Evaluate Every Three-Week Maintenance Dosing of Darbepoetin alfa Therapy in Anemic Subjects with Non-Myeloid Malignancies Receiving Chemotherapy, Principal Investigator • Amgen, A Randomized, Open-Label, Multicenter Study of Darbepoetin alfa Administered Once Every 2 Weeks (Q2W) Compared with Epoetin alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects with Non-Myeloid Malignancies Receiving Multicycle Chemotherapy, Principal Investigator • Amgen, A Study to Evaluate the Effectiveness of Aranesp at 300 mcg Q3W on Clinical Outcomes in Cancer Patients with Anemia Due to Chemotherapy, Principal Investigator • Amgen, A Multicenter, Open-Label Phase 4 Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy, Principal Investigator
- 12. 12 • Amgen, A Dose-Finding Study of Novel Erythropoiesis Stimulating Protein (NESP) Administered by Subcutaneous (SC) Injection for the Treatment of Anemia in Subjects with Chronic Anemia of Cancer, Principal Investigator • Amgen, A Randomized, Dose-Finding Study of Novel Erythropoiesis Stimulating Protein (NESP) Administered by Subcutaneous (SC) Injection for the Treatment of Anemia in Subjects with Solid Tumors Receiving Multicycle Chemotherapy, Principal Investigator • AstraZeneca, A Randomized, Double-Blind Trial Comparing Arimidex Alone with Nolvadex Alone with Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Postmenopausal Women with Breast Cancer, Principal Investigator • AstraZeneca, A Randomized, Double-Blind Trial Comparing Arimidex Alone with Nolvadex Alone with Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women with Breast Cancer, Principal Investigator • AstraZeneca, An Expanded Access Clinical Program with ZD 1839 (Iressa) for Patients with Advanced Non- Small Cell Lung Cancer (NSCLC), Principal Investigator • AstraZeneca, A Double-Blind, Randomized, Multicenter Trial Comparing the Efficacy and Tolerability of 1245 and 250 mg of Faslodex (Long-acting ICI 182,780) With 1 mg Arimidex (Anastrozole) in Postmenopausal Women with Advanced Breast Cancer, Principal Investigator • AstraZeneca, A Double-Blind, Randomized, Multicenter Trial Comparing the Efficacy and Tolerability of 250 mg Faslodex (Long-acting ICI 182,780) with 20 mg of Nolvadex (Tamoxifen) in Postmenopausal Women with Advanced Breast Cancer, Principal Investigator • Aventis, A Multicenter, Phase III, Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed by Docetaxel (AC → T) with Doxorubicin and Cyclophosphamide Followed by Docetaxel and Trastuzumab (AC → TH) and with Docetaxel, Carboplatin and Trstuzumab (TCH) in the Adjuvant Treatment of Node Positive and High-Risk Node Negative Patients with Operable Breast Cancer Containing the HER2/neu Alteration, Principal Investigator • Aventis, A Multicenter, Randomized Phase II Study of Two Schedules of Taxotere (Weekly versus Every 3 Weeks) in Elderly or Poor Performance (ECOG PS 2), Chemotherapy-Naïve Patients with Advanced Non- Small Cell Lung Cancer, Principal Investigator • Aventis, A Randomized, Phase II/III Study Comparing Two Combination Modalities of IV HMR 1275 (Flavopiridol) and IV Docetaxel (Taxotere) with IV Docetaxel (Taxotere) Alone in Patients with Non-Small Cell Lung Cancer (NSCLC) Previously Treated with Platinum-based Chemotherapy, Principal Investigator • Aventis, An Open-label, Expansion Study Following the HMR4396B/3001 Study (A Double-Blind, Placebo- Controlled, Parallel Arms, Dose Response Study of Two Doses of HMR4396 versus Placebo for Anemia in Subjects Treated with Chemotherapy), Principal Investigator • Aventis, Open-Label, Randomized, Multicenter Phase II/III Study of Docetaxel in Combination with Cisplatin (CDDP) or Docetaxel in Combination with 5-Fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients with Metastatic or Locally Recurrent Gastric Cancer Previously Untreated with Chemotherapy for Advanced Disease, Principal Investigator • Berlex, An Open-Label, Single-Arm Trial of Patients with Metastatic Colorectal Cancer Receiving Irinotecan, 5-Fluororacil and Leucovorin Followed by Leukine (Sargramostim), A Recombinant Human Granulocyte- Macrophase Colony Stimulating Factor (FM-CSF), Principal Investigator • Bristol-Myers, A Phase III, Randomized, Multicenter Study of Cetuximab, Oxaliplatin, 5-Flurouracil, and Leucovorin vs. Oxaliplatin, 5-Flurouracil, and Leucovorin in Patients with Previously Treated Metastatic, EGFR-Positive Colorectal Carcinoma, Principal Investigator • Bristol-Myers, A Randomized, Multicenter, Phase II Study of Taxane/Carboplatin/Cetuximab or Taxane/Carboplatin as First-Line Treatment for Patients with Advanced/Metastatic Non-Small Cell Lung Cancer, Principal Investigator • Cell Genesys, A Phase 3, Randomized, Open-Label Study of CG1940 and CG8711 versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve, Principal Investigator • Centocor, A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Anti-TNFa Monoclonal Antibody (Infliximab) to Treat Cancer-Related Cachexia in Subjects with Pancreatic Cancer, Principal Investigator
- 13. 13 • DuPont, A Phase II, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Innohepa (Tinzaparin Sodium) for Primary Prevention of Venous Thromboembolism and Reduction of Mortality in Subjects with Advanced Cancer, Sub-Investigator • Eli Lilly, Randomized Trial of Gemcitabine Plus Docetaxel vs Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd Line Patients, Principal Investigator • Eli Lilly, A Phase 3 Trial of Alimta versus Docetaxel in Patients with Locally Advanced or Metastatic Non- Small Cell Lung Cancer (NSCLC) Who Were Previously Treated with Chemotherapy, Principal Investigator • Eli Lilly, A Phase 3 Trial of Alimta Plus Gemzar versus Gemzar in Patients with Unresectable or Metastatic Cancer of the Pancreas, Principal Investigator • Eli Lilly, Open-Label Study of Alimta (Pemetrexed) Alone or in Combination with Cisplatin for Patients with Malignant Mesothelioma, Sub-Investigator • Eli Lilly, A Randomized, Multicenter Study of Combination Study of Combination Gemcitabine Therapy Followed by Subsequent Single Agent Gemcitabine Maintenance Therapy or Best Supportive Care in Advanced Non-Small Cell Lung Cancer (NSCLC), Principal Investigator • Endo Pharmaceuticals, A Randomized, Double-Blind, Two-Period Crossover Trial Comparing the Safety and Effectiveness of Numorphan CR (Oxymorphone Controlled-Release Tablets) and MS Contin for the Relief of Moderate to Severe Pain in Patients with Cancer, Sub-Investigator • Endo Pharmaceuticals, A Randomized, Double-Blind, Two-Period Crossover Study Comparing the Efficacy, Safety and Tolerability of Numorphan CR (Oxymorphone HCL, Controlled-Release) and OxyContin (Oxycodone HCL, Controlled Release) in Cancer Patients Who Require Chronic Opioid Treatments, Sub- Investigator • Genentech, A Multicenter, Phase III, Randomized Trial Comparing Docetaxel (Taxotere) and Trastuzumab (Herceptin) with Docetaxel (Taxotere), Platinum Salt (Cisplatin or Carboplatin) and Trastuzumab (Herceptin) as First-Line Chemotherapy for Patients with Advanced Breast Cancer Containing HER2 Gene Amplification, Principal Investigator • Genentech, Clinical Outcomes in Patients with HER2 Gene-Amplified Metastatic Breast Cancer Treated with First-Line Herceptin in Combination with Taxane: A Phase IV, Prospective Community-Based Study, Principal Investigator • Genta, Randomized Study of Docetaxel versus Docetaxel Plus Genasense (G3139; Bcl-2 Antisense Oligonucleotide) in Patients with Previously Treated Non-Small Cell Lung Cancer, Sub-Investigator • Glaxo, A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects, Principal Investigator • Glaxo Wellcome, A Prospective, Randomized, Multicenter Phase III Clinical Trial Comparing the Effects of Panorex (17-1A Monoclonal Antibody) Injection Plus 5-Fluorouracil Plus Levamisole versus 5-Flurouracil plus Levamisole in Patients with Surgically Resected Stage III Carcinoma of the Colon, Principal Investigator • Helsinn, A Double-Blind Clinical Study to Compare Single IV Doses of Palonosetron, 0.25 mg or 0.75 mg, and Ondansetron, 32 mg IV, in the Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting, Sub-Investigator • Helsinn, A Double-Blind Clinical Study to Compare Single IV Doses of Palonosetron, 0.25 mg or 0.75 mg, and Ondansetron, 32 mg IV, in the Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting, Sub-Investigator • Hoffmann-La Roche, An Open-Label Randomized Phase 3 Study Comparing Zeloda (Capecitabine) with I.V. Bolus, 5-Fluorouracil in Combination with Low-Dose Leucovorin as Adjuvant Chemotherapy in Patients Who Underwent Surgery for Dukes’ C Colon Cancer, Principal Investigator • Hoffmann-La Roche, An Open-Label, Phase II Study of Intermittent Oral Capecitabine in Combination with Intravenous Irinotecan (Q3W) in Patients with Advanced and/or Metastatic Colorectal Cancer, Principal Investigator • Janssen, Randomized Phase II Trial to Evaluate the Effect of Gemcitabine Plus R115777 versus Gemcitabine Plus Placebo on Time to Deterioration in Patients with Advanced Pancreatic Cancer, Sub-Investigator • Ligand, Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients with Advanced or Metastatic Non-Small Cell Lung Cancer, Principal Investigator • Merck, A Study Evaluating the Efficacy, Safety, and Tolerability of L-377,202 in Bi-Dimensionally Measurable, Androgen/Independent Prostate Cancer, Principle Investigator
- 14. 14 • Merck, Study of Chemotherapy and Patient Health Outcomes for Nausea & Emesis, Principal Investigator • Novartis, An Open-Label, Randomized, Multicenter Study to Evaluate the Use of Zoledronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women in ER + Breast Cancer Receiving Letrozole as Adjuvant Therapy, Principal Investigator • Ortho Biotech, A Randomized, Open-Label Trial Comparing Treatment with Either Peylated Liposomal Doxorubicin or Capecitabine as First-Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older, Principal Investigator • Ortho Biotech, An Open-Label Study of Procrit (Epoetin alfa) in Women Undergoing Adjuvant Chemotherapy for Stage I, II, or III Breast Cancer, Sub-Investigator • Ortho Biotech, A Randomized, Open-Label Study of Procrit versus Darbepoetin alfa (Aranesp) to Evaluate Hematologic Response Rate in Anemic Cancer Patients Receiving Chemotherapy, Principal Investigator • Ortho Biotech, A Pilot Study to Evaluate the Response Rate of Procrit (Epoetin alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy or Radiation therapy, Principal Investigator • Ortho Biotech, A Randomized, Open-Label Study of Procrit versus Darbepoetin alfa (Aranesp) to Evaluate Hematologic Response Rate in Anemic Cancer Patients Receiving Chemotherapy, Principal Investigator • Ortho Biotech, A Pilot Study to Evaluate the Response Rate of Procrit (Epoetin alfa) at 60,000 Units Every Two Weeks in Anemic Patients with Cancer Not Receiving Chemotherapy or Radiation Therapy, Principal Investigator • OSI Pharmaceuticals (Cell Pathways), A Phase III, Randomized, Double-Blind, Multicenter Study of the Efficacy of Taxotere (Docetaxel) in Combination with Aptosyn (Exisulind) versus Taxotere (Docetaxel) and Placebo in Non-Small Cell Lung Cancer (NSCLC) Patients After Failure of Prior Platinum-Based Chemotherapy, Principal Investigator • Pfizer/Pharmacia, Phase III, Randomized Study of Epirubicin/Cyclophosphamide Followed by Taxane (Sequential Chemotherapy) versus Epirubicin/Taxane (Concurrent Chemotherapy) as Adjuvant Treatment for Operable, Node-Positive Breast Cancer, Principal Investigator • Pfizer/Pharmacia, A Randomized, Phase III Trial Comparing CPT-11 (Irinotecan HCI; Camptosa Injection)/Cisplatin with Etoposide/Cisplatin in Patients with Previously Untreated, Extensive, Small-Cell Lung Cancer, Principal Investigator • Pharmacia & Upjohn, A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Fragmin (5,000 IR Subcutaneously) in Preventing Catheter-Related Complications when Given Daily to Cancer Patients with Central Venous Catheters, Sub-Investigator • Sanofi, A Multicenter Study Evaluating the Addition of Oxaliplatin to 5-FU-based Chemotherapy in Subjects with Advanced Refractory Colorectal Cancer, Sub-Investigator • Sanofi, A Phase II, Randomized, Multicenter Comparison of the Efficacy of Oxaliplatin in Four Schedules of 5- Fluorouracil with and without Leucovorin in Previously Untreated Advanced Colorectal Cancer, Principal Investigator • Sanofi, A Multicenter, Phase II Study of Oxaliplatin Single Agent as Third Line Treatment of Metastatic Colorectal Carcinoma, Principal Investigator • Searle, A Randomized, Double-Blind, Placebo-Controlled Comparison of the Analgesic Activity of Valdecoxib (SC-65872) 40 mg BID as Add-On Therapy to Opioid Medication in Patients with Chronic Cancer Pain, Sub- Investigator • SmithKlineBeecham, An Open-Label, Multicenter, Randomized, Phase II, Comparator Study of Oral Topotecan versus Intravenous Topotecan for Second-Line Therapy in Patients with SCLC Who Have Relapsed Greater than or Equal to 90 Days After Completion of First-Line Therapy, Sub-Investigator • SuperGen, Phase III, Randomized Study of RFS 2000-06 (9-Nitro-Camptothecin, 9-Nc) versus 5-Fluorouracil (5-Fu) in Pancreatic Cancer Patients that have Progressive Disease Following Gemcitabine Hcl Treatment, Sub- Investigator • GlaxoSmithKline, A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects, Principal Investigator • Ortho Biotech, A Randomized, Open-Label Study of Procrit (Epoetin alfa) Initiated at 40,000 Units Every Week versus 80,000 Units Every Two Weeks in Anemic Patients with Cancer Receiving Chemotherapy, Principal Investigator • Genentech, The National Lymphocare Study: An Observational Study of Treatment, Outcomes, and Prognosis in Patients with Follicular Non-Hodgkin’s Lymphoma, Sub-Investigator
- 15. 15 • Helsinn, Multicenter, Phase III, Open-Label, Uncontrolled Study to Assess the Safety and Efficacy of a Single Oral Dose of Palonosetron 0.75 mg in the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Patients Undergoing Repeated Cycle of Moderately Emetogenic Chemotherapy, Principal Investigator • Helsinn, Single Dose, Randomized, Double-Blind, Parallel Group, Multicenter Study of Palonosetron 0.25 mg, 0.50 mg and 0.75 mg Administered by the Oral Route versus Palonosetron 0.25 mg IV for the Prevention of Moderately Emetogenic Chemotherapy-Induced Nausea and Vomiting in Patients with Cancer, Principal Investigator • Amgen, A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab with and without Panitumumab in the First-Line Treatment of Subject with Metastatic Colorectal Cancer, Sub- Investigator • Amgen, Flexibility: A Study to Assess the Impact of Once per Cycle Correction and Maintenance Dosing of Darbepoetin alfa in Subjects with Non-Myeloid Malignancies with Anemia Due to Chemotherapy, Principal Investigator • Celgene, A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single- Agent Lenalidomide (Revlimid, CC-5013) in Subjects with Relapsed or Refractory Aggressive Non-Hodgkin’s Lymphoma, Principal Investigator • GlaxoSmithKline, A Phase III, Randomized, Open-Label, Multicenter Study Comparing GW572016 and Capecitabine (Xcloda) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer, Principal Investigator • GlaxoSmithKline, A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer Pain, Principal Investigator • Endo Pharmaceuticals, A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of EN3267 for Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients Followed by an up to 12-Month, Non-Randomized, Open-Label Extension to Assess Long-Term Safety, Principal Investigator • Genentech, An Observational Cohort Study of Patients with HER2-Positive Metastatic Breast Cancer, Sub- Investigator • BioDelivery, A Double-Blind, Placebo-Controlled Evaluation of Efficacy, Safety and Tolerability of BEMA Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects, Principal Investigator • Point Therapeutics, A Phase 3, Randomized, Double-Blind, Multicenter Study of Talabostat and Pemetrexed versus Pemetrexed and Placebo in Patients with Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy, Principal Investigator • Bio-Delivery, An Open-Label, Long-Term Treatment Evaluation of the Safety of BEMA Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy, Principal Investigator • Berlex, Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients with Metastatic Breast Cancer, Principal Investigator • Strakan Pharmaceuticals, A Randomized, Active-Control, Double-Blind, Double-Dummy, Parallel-Group, Multi-National Study to Assess the Efficacy, Tolerability and Safety of the Granisetron Transdermal Delivery System (GTDS) in Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with the Administration of Moderate or Highly Emetogenic Multi-Day Chemotherapy, Principal Investigator • Genentech, A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy with or without Erlotinib After Completion of Chemotherapy with Bevacizumab for the First-Line Treatment of Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer, Principal Investigator • Taiho, A Phase II, Randomized, Double-Blinded Efficacy and Safety Study of Three Doses of TAS-108 Administered Orally in Postmenopausal Patients with Locally Advanced or Locally Recurrent Inoperable or Progressive Metastatic Breast Carcinoma Following Standard First-Line Endocrine Therapy, Principal Investigator • AstraZeneca, A Randomized, Double-Blind, Parallel Group, Multicenter, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (Faslodex) 500 mg with Fulvestrant (Faslodex) 250 mg in Postmenopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy, Principal Investigator
- 16. 16 • Celgene, A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single- Agent Lenalidomide (Revlimid, CC-5013) in Subjects with Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma, Principal Investigator • GlaxoSmithKline, An Observational Study to Characterize the Burden of Illness Associated with Laxative Use in Subjects Using Opioids for the Management of Persistent Pain, Principal Investigator (2006) • Berlex, Phase 2 Study of ZK-Epothiline (ZK-Epo; ZK 219477) Plus Prednisone as First-Line Chemotherapy in Patients with Metastatic Androgen-Independent Prostate Cancer, Principal Investigator (2007) • GlaxoSmithKline, A Phase III, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant (GW679769) in Combination with Ondansetron and Dexamethasone for the Prevention of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy, Principal Investigator (2007) • Amgen, A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab with and without Panitumumab in the First-line Treatment of Subjects with Metastatic Colorectal Cancer, Sub- Investigator (2008) • Genentech, A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination with Tarceva (Erlotinib) Compared with Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) after Failure of Standard First-Line Chemotherapy, Principal Investigator (2008) • Pharmacyclics, Randomized, Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small Cell Lung Cancer, Principal Investigator (2008) • Genentech, A Phase II, Open-Label, Single Arm Study of Tenecteplase for Restoration of Function in Dysfunction Central Venous Access Catheters, Principal Investigator (2008) • Abbott, An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC), Sub-Investigator (2008) • Genentech, A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab, Trastuzumab, Docetaxel vs. Placebo, Trastuzumab, Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer, Sub-Investigator (2008) • Wyeth, An Open-Label, Randomized, Phase 3 Trial of Intravenous Temsirolimus (CC1-779) at Two Dose Levels Compared to Investigator’s Choice Therapy in Relapsed, Refractory Subjects with Mantle Cell Lymphoma (MCL), Principal Investigator (2008) • GTx, A Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (cachexia) in Patients with Cancer, Principal Investigator (2008) • Cell Genesys, A Phase II Randomized, Open-Label Study of CG1940 and CG8711 versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy–Naïve, Principal Investigator (2008) • Genentech, A Phase II Trial of Bevacizumab in Combination with First- or Second-Line Therapy in Subjects with Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer, Principal Investigator (2008) • Amgen, A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma, Sub-Investigator (2009) • Cyclacel, A Phase IIb, Randomized Study of Oral Seliciclib in Patients with Previously Treated Non-Small Cell Lung Cancer, Principal Investigator (2009)