GCIG Rare Tumor Working Group Chicago, IL, June 3, 2010 Chair: Isabelle Ray-Coquard Co-Chair: David M. Gershenson

Active Studies

GOG 187: Phase II Study of Paclitaxel for Ovarian Stromal Tumors Activated Accrual: 26/37 pts. Schema: Paclitaxel 175 mg/m 2 IV Q. 21d as 2 nd line therapy for pts. with measurable disease

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 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 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 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 Schema: Phase II randomized study in 1:1 ratio

Proposed Studies

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.

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

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

GOG 0239R Concepts IMC-A12 Bevacizumab MK-2206 Pazopanib

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