G9923 A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination with Continuous or Intermittent ABT-888 and Bevacizumab in Newly Diagnosed Patients with Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
to determine the maximum tolerated dose and dose-limiting toxicities of ABT-888 when administered with IV carboplatin, paclitaxel and bevicizumab in women with newly diagnosed, previously untreated, epithelial ovarian, fallopian tube and primary peritoneal cancer.
Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, or carcinosarcoma Stage II, III, or IV with either optimal (ï¿½ 1 cm residual disease) or suboptimal residual disease.Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma not otherwise specified (N.O.S.) or carcinosarcoma. Patients must have adequate bone marrow, renal, hepatic, neurologic, and blood coagulation functions as defined by the following: Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3, Platelets greater than or equal to 100,000/mm3. Creatinine ï¿½ 1.5 x ULN Bilirubin less than or equal to 1.5 x ULN (AST) less than or equal to 3 x ULN and alkaline phosphatase less than or equal to 2.5 x ULN Neuropathy (sensory and motor) less than or equal to CTEP Active Version CTCAE Grade 1. INR is ï¿½ 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT less than 1.5 x ULN. Patients must have a GOG performance status of 0, 1, or 2. Patients must be entered between 1 and 12 weeks after initial surgery
Regimen I (Phase A) Paclitaxel 175 mg/m2 Carboplatin AUC 6, Day 1 Bevacizumab 15 mg/kg, Day 1 * ABT-888 twice daily, Days 1-21 Regimen II (Phase A) Day 1 Paclitaxel 80 mg/m2, Days 1,8,15 Carboplatin AUC 6, Day 1 Bevacizumab 15 mg/kg, Day 1 * ABT-888 twice daily, Days 1-21 ** Phase A: Cycle repeated every 21 days for a total of 6 cycles.* Bevacizumab started in cycle 2. Phase B: Bevacizumab will be continued as maintenance for Cycles 7-22 every 21 days.
06/18/2013 04:02 AM