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"Cancer Center Trials at St Barnabas" (ppt)

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  • 1. Cancer Center Trials atCancer Center Trials at St. Barnabas MedicalSt. Barnabas Medical CenterCenter
  • 2.  Oncology clinical research at Saint BarnabasOncology clinical research at Saint Barnabas Medical Center (SBMC) is supported by a staffMedical Center (SBMC) is supported by a staff of three.of three.  The clinical research group manages the studiesThe clinical research group manages the studies in the Cancer Center (Medical Oncology) andin the Cancer Center (Medical Oncology) and The Department of Radiation Oncology. In all,The Department of Radiation Oncology. In all, there are 12 physicians who make up this groupthere are 12 physicians who make up this group of oncologists.of oncologists.
  • 3.  The SBMC was most recently approved withThe SBMC was most recently approved with commendation by the American College ofcommendation by the American College of Surgeons.Surgeons.  Our goal is to accrue approximately 85 patientsOur goal is to accrue approximately 85 patients per year to clinical trials.per year to clinical trials.  Our physicians willingly refer patients to outsideOur physicians willingly refer patients to outside facilities for clinical trials not offered at SBMC.facilities for clinical trials not offered at SBMC.
  • 4.  Most of the trials offered at SBMC areMost of the trials offered at SBMC are treatment-based.treatment-based.  Other types of trials include observational andOther types of trials include observational and prevention studies.prevention studies.
  • 5.  SBMC participates in clinical trials sponsored bySBMC participates in clinical trials sponsored by several National Cancer Institute cooperativeseveral National Cancer Institute cooperative groups and pharmaceutical companies.groups and pharmaceutical companies.  SBMC is considered a member accessible toSBMC is considered a member accessible to trials from CALGB, NSABP, and RTOG.trials from CALGB, NSABP, and RTOG.  Our membership to CTSU allows forOur membership to CTSU allows for participation in a wide range of other NCIparticipation in a wide range of other NCI cooperative group trials as well.cooperative group trials as well.
  • 6.  SBMC is currently enrolling patients in studiesSBMC is currently enrolling patients in studies for the following sites of disease:for the following sites of disease:  Adjuvant and Metastatic Breast CancerAdjuvant and Metastatic Breast Cancer  Primary and Metastatic Brain CancerPrimary and Metastatic Brain Cancer  Adjuvant and Metastatic Gastrointestinal CancerAdjuvant and Metastatic Gastrointestinal Cancer  Recurrent GYN CancerRecurrent GYN Cancer  Adjuvant Genitourinary CancerAdjuvant Genitourinary Cancer  Multiple MyelomaMultiple Myeloma
  • 7.  A complete listing of our studies can be found atA complete listing of our studies can be found at www.sbhcs.comwww.sbhcs.com..  Navigate to the Cancer Center at Saint BarnabasNavigate to the Cancer Center at Saint Barnabas Medical CenterMedical Center
  • 8. Review of Cancer CenterReview of Cancer Center Open TrialsOpen Trials
  • 9.  ECOG E5103 A Double-Blind Phase III Trial of Doxorubicin andECOG E5103 A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or PlaceboCyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Nodein Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast CancerNegative Breast Cancer  NSABP B-39 A Randomized Phase III Study of Conventional WholeNSABP B-39 A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI)Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) forWomen with Stage 0, I, or II Breast CancerforWomen with Stage 0, I, or II Breast Cancer  IBCSG 24-02 A Phase III Trial Evaluating the Role of OvarianIBCSG 24-02 A Phase III Trial Evaluating the Role of Ovarian Suppression and the Role of Exemestane as Adjuvant Therapies forSuppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Breast Cancer (SOFT)Premenopausal Women with Endocrine Breast Cancer (SOFT)  SWOG S0307 Phase III Trial of Bisphosphonates ( Zoledronic acid Vs.SWOG S0307 Phase III Trial of Bisphosphonates ( Zoledronic acid Vs. Clodronate Vs. Ibandronate) as Adjuvant Therapy for Primary BreastClodronate Vs. Ibandronate) as Adjuvant Therapy for Primary Breast CancerCancer.. Breast Cancer Trials Stage I, II, IIIBreast Cancer Trials Stage I, II, III
  • 10.  NSABP B-42 A Clinical Trial to Determine the Efficacy of FiveNSABP B-42 A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients CompletingYears of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an AromataseFive Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in ProlongingInhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with HormoneDisease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast CancerReceptor Positive Breast Cancer  NCCTG N063D/ALTTO Adjuvant Lapatinib and/orNCCTG N063D/ALTTO Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study:  A randomized,Trastuzumab Treatment Optimization Study:  A randomized, multi-center, open-label, phase III study of adjuvant Lapatinib,multi-center, open-label, phase III study of adjuvant Lapatinib, Trastuzumab, their sequence and their combination in patientsTrastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer.with HER2/ErbB2 positive primary breast cancer.  CALGB 369901 Observational Cohort Study: chemotherapyCALGB 369901 Observational Cohort Study: chemotherapy decisions and outcomes in women age 65 or older with operable,decisions and outcomes in women age 65 or older with operable, newly diagnoses breast cancer.newly diagnoses breast cancer.  WYETH 3144A2-3004 WW A Randomized Double-BlindWYETH 3144A2-3004 WW A Randomized Double-Blind Placebo Controlled Trial of Neratinib (HKI-272) AfterPlacebo Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women With Early-Stage HER-2/neuTrastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast  Overexpressed/Amplified Breast  
  • 11.   Breast Cancer Trials MetastaticBreast Cancer Trials Metastatic  CZOL446E2352 A prospective, randomized, stratified, placebo-controlled,CZOL446E2352 A prospective, randomized, stratified, placebo-controlled, multi-center, 2-arm trial of the continued efficacy and safety of Zometamulti-center, 2-arm trial of the continued efficacy and safety of Zometa (every 4 weeks vs. every 12 weeks) in patients with documented bone(every 4 weeks vs. every 12 weeks) in patients with documented bone metastases from breast cancer.metastases from breast cancer.  TOC4129g A Phase III, Randomized, Double-Blind, Placebo-ControlledTOC4129g A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab +Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel inTrastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast CancerPreviously Untreated Her2-Positive Metastatic Breast Cancer  CALGB 40302 Endocrine Therapy With or Without Inhibition of EGF &CALGB 40302 Endocrine Therapy With or Without Inhibition of EGF & HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo- Controlled Phase III Trial of Fulvestrant with or without Lapatanib forControlled Phase III Trial of Fulvestrant with or without Lapatanib for Postmenopausal Women with ER &/or PR Positive Advanced BreastPostmenopausal Women with ER &/or PR Positive Advanced Breast CancerCancer  Celsion A Phase I-II Study Evaluating the Maximum Tolerated Dose,Celsion A Phase I-II Study Evaluating the Maximum Tolerated Dose, Pharmacokinetics, Safety, and Efficacy of Microwave Hyperthermia andPharmacokinetics, Safety, and Efficacy of Microwave Hyperthermia and Thermodox (Lyso-Thermosensitive Liposomal Doxorubicin) in PatientsThermodox (Lyso-Thermosensitive Liposomal Doxorubicin) in Patients With Breast Cancer Recurrence at the Chest WallWith Breast Cancer Recurrence at the Chest Wall
  • 12.   Multiple MyelomaMultiple Myeloma  C05009 Randomized Phase III study of 3 NovelC05009 Randomized Phase III study of 3 Novel treatment regimens in subjects with previouslytreatment regimens in subjects with previously untreated multiple myeloma who are notuntreated multiple myeloma who are not considered candidates for high dose chemotherapyconsidered candidates for high dose chemotherapy and autologous stem cell transplantation: Velcadeand autologous stem cell transplantation: Velcade (Bortezomib), Thalomid (Thalidomide), and(Bortezomib), Thalomid (Thalidomide), and Dexamethasone (VTD) vs. Velcade andDexamethasone (VTD) vs. Velcade and Dexamethasone (VD) vs. Velcade, Melphalan, andDexamethasone (VD) vs. Velcade, Melphalan, and Prednisone (VMP) Prednisone (VMP) 
  • 13. Gastrointestinal, MetastaticGastrointestinal, Metastatic  SWOG S0600 Phase III Trial of Irinotecan-BasedSWOG S0600 Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) orChemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) As Second-LineBevacizumab (NSC-704865) As Second-Line Therapy For Patients With Metastatic ColorectalTherapy For Patients With Metastatic Colorectal Cancer Who Have Progressed on BevacizumabCancer Who Have Progressed on Bevacizumab with Either FOLFOX, OPTIMOX, XELOXwith Either FOLFOX, OPTIMOX, XELOX
  • 14. Gastrointestinal STAGE I, II, IIIGastrointestinal STAGE I, II, III  ECOG E5202 A Randomized Phase III StudyECOG E5202 A Randomized Phase III Study Comparing 5FU, Leucovorin and OxaliplatinComparing 5FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin andversus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II ColonBevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to DetermineCancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of MolecularProspectively the Prognostic Value of Molecular MarkersMarkers      
  • 15. GenitourinaryGenitourinary  ECOG E2805 A Randomized, Double-BlindECOG E2805 A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib vsPhase III Trial of Adjuvant Sunitinib vs Sorafenib vs Placebo in Patients with ResectedSorafenib vs Placebo in Patients with Resected Renal Cell Carcinoma Renal Cell Carcinoma 
  • 16. Brain, AdjuvantBrain, Adjuvant  RTOG 0825 Phase III Double-Blind Placebo-RTOG 0825 Phase III Double-Blind Placebo- Controlled Trial of Conventional ConcurrentControlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide PlusChemoradiation and Adjuvant Temozolomide Plus Bevacizumab vs. Conventional ConcurrentBevacizumab vs. Conventional Concurrent Chemoradiation and Adjuvant Temozolomide InChemoradiation and Adjuvant Temozolomide In Patients with Newly Diagnosed GlioblastomaPatients with Newly Diagnosed Glioblastoma Brain, MetastaticBrain, Metastatic  RTOG 0614 A Randomized Phase III Double-BlindRTOG 0614 A Randomized Phase III Double-Blind Placebo Controlled Trial of Memantine forPlacebo Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in PatientsPrevention of Cognitive Dysfunction in Patients receiving Whole Brain Radiotherapy receiving Whole Brain Radiotherapy 
  • 17. Gynecological Cancers,Gynecological Cancers,  OvarianOvarian  AVF4095g A Phase III, Multicenter,AVF4095g A Phase III, Multicenter, Randomized, Blinded, Placebo-Randomized, Blinded, Placebo- Controlled Trial of Carboplatin andControlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in PatientsGemcitabine Plus Bevacizumab in Patients With Platinum-Sensitive Recurrent Ovary,With Platinum-Sensitive Recurrent Ovary, Primary Peritoneal or Fallopian TubePrimary Peritoneal or Fallopian Tube Carcinoma  Carcinoma  
  • 18. Upcoming trialUpcoming trial  Collaboration with Genomic Health forCollaboration with Genomic Health for participation in a Registry Study forparticipation in a Registry Study for Oncotype DX in Breast Cancer in theOncotype DX in Breast Cancer in the Neo-adjuvant and Adjuvant settingNeo-adjuvant and Adjuvant setting
  • 19. For more information on any of ourFor more information on any of our studies contact:studies contact: Elyce Hirtler,Elyce Hirtler, Research ManagerResearch Manager 973-322-2527973-322-2527 ehirtler@sbhcs.comehirtler@sbhcs.com