Recommendations:

1. Recruitment to clinical trials

• Develop a Working Group of advocates and investigators, including Gynecologic Cancer Foundation, GOG, SPOREs, NCI phase II contract holders, industry, and NCI
• Create more links between patients and open trials

2. Histology and trial design

• Separate trials for mucinous and clear cell histology
• Phase II trials: need more development from GOG Rare Tumor Working Group and Gynecologic Cancer Intergroup (GCIG)
• Phase III trials: need more development from GCIG
• Need early confirmation of patient eligibility

3. Alternative phase II design

• Randomized phase II
• One stage phase I
• Novel statistical designs, multiple primary endpoints, etc.
• Develop new Working Group including GOG, NCI, GCIG statisticians, trialists

4. Accrual to challenging phase I-II trials

• Develop new Working Group including SPORE, GOG, contract holders, NCI
• One-day retreat for Working Group members
• Report with recommendations by January 2006?

5. Faster start and completion of phase II trials

• Reorganization of GOG institutions into mini-consortia for phase II trials
• Say, 10 institutions per trial
• Streamlined paperwork
• Prioritization of translational endpoints
• GOG statisticians, data managers, Committee on Experimental Medicine, trialists, NCI

6. Central review and monitoring for select phase II trials

• Open phase II trials on CTSU
• Use CIRB review
• NCI: explore options and review with GOG, SPOREs, contract holders

7. CA 125

• Consider CA 125 for expanded eligibility and response in phase II trials
• Trials to include two cohorts: measurable and CA 125 evaluable disease
• Use GCIG CA 125 criteria
• NCI, GOG, SPOREs, FDA

8. Endpoints in phase III ovarian cancer trials

• CA 125 rise as marker for progression
• PFS as proxy for survival
• FDA plans workshop; has asked for input from NCI (+GCIG), ASCO, AACR
• FDA to present report to ODAG
• Perhaps an NCI (+GCIG) meeting with FDA, EMEA, Canadian and other regulatory bodies after FDA report to ODAG

9. Intraperitoneal therapy

• Need to decrease toxicity
• Explore mechanism of action
• Need to explore novel agents and combinations
• How to combine IP therapy for optimally debulked stage III patients with other interventions
• GOG, SPOREs, Cancer Centers , NCI, GCIG

10. NCI Clinical Announcement

• How to avoid toxicity
• How to place catheters and administer chemotherapy
• Dissemination with advocacy groups and professional societies
• Evaluate uptake in prospective cohorts through National Comprehensive Cancer Network, National Cancer Databank, CMS (SEER Medicare), CanCors?

11. Genomics/ proteomics

• Develop new Working Group including NCI, SPOREs, Director's Challenge, DOD, GOG, GCIG, etc.
• Review published microarray data
• Review ongoing projects
• 6-12 months: planning workshop
• Design and implement validation studies
• Monitor tissue collections and use for proteomics studies