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

Agenda: 1.Review of current clinical trials with update of status 2.Review of clinical trials in development 3.Establishment of listings of above to place on GCIG web site 4.Discussion of strategies and barriers to promote international collaboration 5.Potential future collaborations with IGCS 6.Roster of core members of Rare Tumor Working Group 7.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

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)

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

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 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 Randomize 332 pts. Activated in US, 1500 pts attended

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

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 1 st stage accrual 2 nd stage opened 9-10 Accrual to date: 27 pts. Schema: Bevacizumab 15 mg/kg IV Q. 21d for pts. with measurable disease

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

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: pts Activated 2-10 Accrual to date: 2 pts. Schema: Phase II randomized study in 1:1 ratio

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 or until disease progression Target accrual: 45 pts. Activated 8-10 Accrual to date: 1 pt.

Proposed GOG Studies

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

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

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

Other proposals: Philip Harter for uterine leiomyosarcoma ?

Agenda: 1.Review of current clinical trials with update of status 2.Review of clinical trials in development 3.Establishment of listings of above to place on GCIG web site 4.Discussion of strategies and barriers to promote international collaboration 5.Potential future collaborations with IGCS (M Bookman) 6.Roster of core members of Rare Tumor Working Group 7.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

Agenda: 1.Review of current clinical trials with update of status 2.Review of clinical trials in development 3.Establishment of listings of above to place on GCIG web site 4.Discussion of strategies and barriers to promote international collaboration 5.Potential future collaborations with IGCS 6.Roster of core members of Rare Tumor Working Group 7.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

Agenda: 1.Review of current clinical trials with update of status 2.Review of clinical trials in development 3.Establishment of listings of above to place on GCIG web site 4.Discussion of strategies and barriers to promote international collaboration 5.Potential future collaborations with IGCS 6.Roster of core members of Rare Tumor Working Group 7.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

Agenda: 1.Review of current clinical trials with update of status 2.Review of clinical trials in development 3.Establishment of listings of above to place on GCIG web site 4.Discussion of strategies and barriers to promote international collaboration 5.Potential future collaborations with IGCS 6.Roster of core members of Rare Tumor Working Group 7.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

Agenda: 1.Review of current clinical trials with update of status 2.Review of clinical trials in development 3.Establishment of listings of above to place on GCIG web site 4.Discussion of strategies and barriers to promote international collaboration 5.Potential future collaborations with IGCS 6.Roster of core members of Rare Tumor Working Group 7.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