G0264 A Randomized 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
To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin (BEP) as a reference) for newly diagnosed advanced or recurrent chemonaive ovarian sex cordstromal tumors.To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide,and cisplatin in this patient population. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP. To evaluate response rate in the subset of patients with measurable disease.
Patients diagnosed with histologically confirmed ovarian stromal tumor [granulosa cell tumor, granulosa cellâ??theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules]. Patients must have newly diagnosed, Stage IIA â?? IV disease and must be entered within eight weeks from surgery; they may have either measurable residual disease by RECIST criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy. Absolute neutrophil count greater than or equal to 1,500/mcl Platelets greater than or equal to 100,000/mcl. Creatinine less than or equal to 1.5 x ULN Bilirubin less than or equal to 1.5 x ULN SGOT (AST) less than or equal to 3.0 x ULN alkaline phosphatase less than or equal to 2.5 x ULN normal lung expansion, absence of crackles on auscultation, and normal carbon monoxide diffusion (DLCO), defined as greater than 80% predicted. Patients must be â?¥ 18 years of age.
Arm I Treatment: â?¢ Paclitaxel 175 mg/m2 IV over 3 hours â?¢ Carboplatin AUC equal to 6 IV over 1 hour â?¢ Every 3 weeks x 6 cycles ( equal to 18weeks Arm II Treatment: â?¢ Bleomycin 20 units/m2 IV Push day 1 (MAX 30 units/cycle; Total lifetime cumulative dose should not exceed 120 units) â?¢ Etoposide** 75 mg/m2 IV Day 1,2,3,4,5 â?¢ Cisplatin 20 mg/m2 IV Day 1,2,3,4,5 â?¢ Every 3 weeks x 4 cycles ( equal to 12 weeks)
12/05/2013 04:02 AM