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GCIG Rare Tumor Working Group Prague, CZ, October, 2010

GCIG Rare Tumor Working Group Prague, CZ, October, 2010. Chair: Isabelle Ray-Coquard Co-Chair: David M. Gershenson. Agenda:. Review of current clinical trials with update of status Review of clinical trials in development Establishment of listings of above to place on GCIG web site

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GCIG Rare Tumor Working Group Prague, CZ, October, 2010

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  1. GCIG Rare Tumor Working GroupPrague, CZ, October, 2010 Chair: Isabelle Ray-Coquard Co-Chair: David M. Gershenson

  2. Agenda: • Review of current clinical trials with update of status • Review of clinical trials in development • Establishment of listings of above to place on GCIG web site • Discussion of strategies and barriers to promote international collaboration • Potential future collaborations with IGCS • Roster of core members of Rare Tumor Working Group • approval for the Q&A issues with  providing commentary and feedback on submitted Q & As, and also agreement  to publish this as an audit of activity

  3. Active GOG Studies • GOG 187 (stromal tumors) • GOG 241 (MOC) • GOG 239 (low grade serous carcinoma) • GOG 251 (sex cords tumors) • GOG 245 (clear cell carcinoma) • GOG 0264 (sex cords tumors) • GOG 0268 (clear cell carcinoma)

  4. GOG 187: Phase II Study of Paclitaxel for Ovarian Stromal Tumors • Activated 11-2000 • Accrual: 27/37 pts. • Schema: Paclitaxel 175 mg/m2 IV Q. 21d as 2nd line therapy for pts. with measurable disease

  5. GOG 241: A GCIG Intergroup multicentre phase III trial of open label carboplatin and paclitaxel +/- bevacizumab compared with oxaliplatin and capecitabine +/- bevacizumab as first line chemotherapy in patients with mucinous epithelial ovarian cancer (mEOC) Newly Diagnosed Stage II-IV or Recurrent Stage I Mucinous Ovarian Carcinoma Randomize 332 pts. Paclitaxel 175 mg/m2 Carboplatin AUC 6 Q. 21d X 6 Paclitaxel 175 mg/ m2 Carboplatin AUC 6 Bevacizumab 15 mg/kg Q. 21d X 6 Capecitabine 850 mg/m2 bd Oxaliplatin 130 mg/m2 Q. 21d X 6 Capecitabine 850 mg/m2 bd Oxaliplatin 130 mg/m2 Bevacizumab 15 mg/kg Q. 21d X 6 Bevacizumab 15 mg/kg Q. 21d X 12 Bevacizumab 15 mg/kg Q. 21d X 12 Activated 10-10 in US, 1500 pts attended

  6. GOG 239: Phase II Trial of AZD6244 in Women with Recurrent Low-Grade Serous Carcinoma of Ovary/Peritoneum • Activated 12-07 • Completed 1st stage accrual of 27 pts. in 9 mo. • Second stage opened on 5-26-09 • Accrual (52 pts.) completed in 11-09 • Awaiting analysis • Schema: AZD6244 for pts. with recurrent low-grade serous carcinoma with measurable disease

  7. GOG 251: Phase II Trial of Bevacizumab for Recurrent Sex Cord-Stromal Tumors of the Ovary • Activated 9-08 • Target accrual: Up to 37 pts. in 2-stage design • Completed 1st stage accrual • 2nd stage opened 9-10 • Accrual to date: 27 pts. • Schema: Bevacizumab 15 mg/kg IV Q. 21d for pts. with measurable disease

  8. GOG 254: Phase II evaluation of SU 11248 (sunitinib malate) in the treatment of persistent or recurrent clear cell ovarian carcinoma • Target accrual: 36-43 pts. in 2-stage design • Measurable disease • Activated in 4-10 • Accrual to date: 1 pt. • Schema: Sunitinib 50 mg QD

  9. GOG 0264: Phase II trial of paclitaxel and carboplatin vs. bleomycin, etoposide, and cisplatin for newly diagnosed advanced stage and recurrent chemonaive sex cord-stromal tumors of the ovary • Target accrual: 80-128 pts • Activated 2-10 • Accrual to date: 2 pts. • Schema: Phase II randomized study in 1:1 ratio

  10. GOG 0268: A phase II evaluation of temsirolimus (CCI-779) in combination with carboplatin and paclitaxel followed by temsirolimus (CCI-779) consolidation as first-line therapy in the treatment of stage III-IV clear cell carcinoma of the ovary • Schema: Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC = 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg/kg weekly on Days 1, 8 and 15 every 3 weeks, cycles 7-22 or until disease progression • Target accrual: 45 pts. • Activated 8-10 • Accrual to date: 1 pt.

  11. Proposed GOG Studies

  12. RTM 0905: A phase II study of Dasatinib (Sprycel) in the treatment of vulvovaginal melanoma harboring somatic alterations of c-KIT • Study likely to be integrated into second stage of ongoing ECOG trial with separate cohort for women with vulvovaginal melanoma • Schema: Dasatinib 70 mg bid

  13. Other International Studies • ANZGOG: Phase 2 study of ARomatase inhibitors in women with potentially hormone responsive recurrent/metastatic Gynaecological Neoplasms (PARAGoN) • JGOG: Phase III randomized trial of irinotecan + cisplatin versus paclitaxel + carboplatin in treatment of newly diagnosed advanced stage clear cell carcinoma of the ovary

  14. UBC Study Proposal:Lapatanib or Traztusumab for Recurrent Ovarian Mucinous Carcinoma • Rationale: mucinous carcinomas overexpress HER-2/neu in 20% of cases • Extreme rarity of tumor type would likely require international participation • Surveying interest of GCIG cooperative groups

  15. Other proposals: • Philip Harter for uterine leiomyosarcoma • ?

  16. Agenda: • Review of current clinical trials with update of status • Review of clinical trials in development • Establishment of listings of above to place on GCIG web site • Discussion of strategies and barriers to promote international collaboration • Potential future collaborations with IGCS (M Bookman) • Roster of core members of Rare Tumor Working Group • approval for the Q&A issues with  providing commentary and feedback on submitted Q & As, and also agreement  to publish this as an audit of activity

  17. Agenda: • Review of current clinical trials with update of status • Review of clinical trials in development • Establishment of listings of above to place on GCIG web site • Discussion of strategies and barriers to promote international collaboration • Potential future collaborations with IGCS • Roster of core members of Rare Tumor Working Group • approval for the Q&A issues with  providing commentary and feedback on submitted Q & As, and also agreement  to publish this as an audit of activity

  18. Agenda: • Review of current clinical trials with update of status • Review of clinical trials in development • Establishment of listings of above to place on GCIG web site • Discussion of strategies and barriers to promote international collaboration • Potential future collaborations with IGCS • Roster of core members of Rare Tumor Working Group • approval for the Q&A issues with  providing commentary and feedback on submitted Q & As, and also agreement  to publish this as an audit of activity

  19. Agenda: • Review of current clinical trials with update of status • Review of clinical trials in development • Establishment of listings of above to place on GCIG web site • Discussion of strategies and barriers to promote international collaboration • Potential future collaborations with IGCS • Roster of core members of Rare Tumor Working Group • approval for the Q&A issues with  providing commentary and feedback on submitted Q & As, and also agreement  to publish this as an audit of activity

  20. Agenda: • Review of current clinical trials with update of status • Review of clinical trials in development • Establishment of listings of above to place on GCIG web site • Discussion of strategies and barriers to promote international collaboration • Potential future collaborations with IGCS • Roster of core members of Rare Tumor Working Group • Approval for the Q&A issues with  providing commentary and feedback on submitted Q & As, and also agreement  to publish this as an audit of activity

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