Current Ovarian Cancer
Protocols
Peter Argenta MD
Division of Gynecologic Oncology
Department of Obstetrics and Gynecology...
Trial Types
• Therapeutic
– Phase I
– Phase II
– Phase III
– Preventative/screening
• Information Gathering
– Discovery
– ...
Current Trials in Ovarian Cancer
• NCI – 103 current trials available
– Includes US, European, and international
– Chemoth...
Phase I
• NCI – 36 Current Phase I trials
• GOG – 2
– CT-2103 + Carboplatin – 1st
line
– Radiation potentiation of Docetax...
Phase II
• NCI – 45 Current Phase II trials
• GOG – 7
– 126 series - Platinum-resistant series
• 126P – Weekly Taxol+Celeb...
Phase II
• University of Minnesota –3
– WCC31 – Topotecan+/- thalidomide
– Biweekly caboplatin + gemcitabine
– Pegfilgrast...
Phase III
• NCI – 13 Current Phase III
• GOG –2+
– GOG 182 – 5 arm doublets and triplets – CLOSED
– GOG 175 – T/C x3 vs. T...
Prevention
• NCI+GOG=UM=Mayo = 2
– GOG-190 Fenretinide
– GOG-199 Risk-reducing surgery
Screening
• NCI – 7 protocols
– 6 for high risk patients only
– 1 for general population
• Most are CA-125 =/- Ultrasound
Discovery
• NCI - ?
• GOG – subset of many
• U of MN – 1+
– MCP-1 in newly diagnosed cancers
– Drug sensitivity assay unde...
Survivorship
• NCI – 10 protocol
• GOG – No open protocols
• U of MN – 4
– Neuropathy reduction using atexakin-α
– Outcome...
Directions
• WWII until 1990’s – ↑ toxicity = ↑efficacy
• 1990’s-2000 – Modified drugs or dosing
results in decreased toxi...
Clinical Trials – What takes so
long?
• Discovery
• Development
– Cost – 2004 > $1,000,000,000.00
• Liability
• Utility
• ...
Solution
COLLABORATION!
Patients
Doctors
Researchers
Industry
Government
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  1. 1. Current Ovarian Cancer Protocols Peter Argenta MD Division of Gynecologic Oncology Department of Obstetrics and Gynecology University of Minnesota
  2. 2. Trial Types • Therapeutic – Phase I – Phase II – Phase III – Preventative/screening • Information Gathering – Discovery – Survivorship • Psychological
  3. 3. Current Trials in Ovarian Cancer • NCI – 103 current trials available – Includes US, European, and international – Chemotherapy, Radiation, Surgical, Transplant • GOG – 14 active trials – 4 additional temporarily closed, 2 in development • University of Minnesota – 11 active trials – Mayo 7 active trials (3 non-overlapping)
  4. 4. Phase I • NCI – 36 Current Phase I trials • GOG – 2 – CT-2103 + Carboplatin – 1st line – Radiation potentiation of Docetaxel – 2nd line • UM –2 – Continuous infusion Docetaxel – Weekly Topotecan
  5. 5. Phase II • NCI – 45 Current Phase II trials • GOG – 7 – 126 series - Platinum-resistant series • 126P – Weekly Taxol+Celebrex • 126Q – Premetrexed (Altima) – 146 series – Platinum sensitive • 146N – PS-341 single agent • 146O- Irofulven single agent • 146P – Carboplatin + Cetuximab • 170F – BAY43-9006 – 9910 P53 vaccination trial
  6. 6. Phase II • University of Minnesota –3 – WCC31 – Topotecan+/- thalidomide – Biweekly caboplatin + gemcitabine – Pegfilgrastim during chemotherapy • Mayo –1 – Thalidomide
  7. 7. Phase III • NCI – 13 Current Phase III • GOG –2+ – GOG 182 – 5 arm doublets and triplets – CLOSED – GOG 175 – T/C x3 vs. T/C x3 + consolidation in early disease – GOG 198 – Tamoxifen vs. Thalidomide in chemical recurrences
  8. 8. Prevention • NCI+GOG=UM=Mayo = 2 – GOG-190 Fenretinide – GOG-199 Risk-reducing surgery
  9. 9. Screening • NCI – 7 protocols – 6 for high risk patients only – 1 for general population • Most are CA-125 =/- Ultrasound
  10. 10. Discovery • NCI - ? • GOG – subset of many • U of MN – 1+ – MCP-1 in newly diagnosed cancers – Drug sensitivity assay under development
  11. 11. Survivorship • NCI – 10 protocol • GOG – No open protocols • U of MN – 4 – Neuropathy reduction using atexakin-α – Outcomes of patients using CAM – Urinary incontinence Survey – Whole foods trial and survey • Mayo – 2 – Experience of partners of patients – Spiritual well-being and overall QOL
  12. 12. Directions • WWII until 1990’s – ↑ toxicity = ↑efficacy • 1990’s-2000 – Modified drugs or dosing results in decreased toxicity – small change in prognosis • 2000+ – Biologic response modifiers – Alternate dosing regimens – Patient/tumor directed therapy – Prevention
  13. 13. Clinical Trials – What takes so long? • Discovery • Development – Cost – 2004 > $1,000,000,000.00 • Liability • Utility • Enrollment – Patient heterogeneity, fears, desires • Analysis – Time to event – Bias – Chance
  14. 14. Solution COLLABORATION! Patients Doctors Researchers Industry Government
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