Conditions: Genital Neoplasms, Female Fallopian Tube Neoplasms Ovarian Neoplasms Pelvic Neoplasms Peritoneal Neoplasms
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 919
Healthy volunteers: no

Brief summary:
This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction therapy will crossover to receive single agent therapy.

Detailed description:
This study (Study B9E-US-S302) is a multicenter, comparative, open-label randomized, superiority, trial evaluating Gemcitabine and Carboplatin to the standard of care. Both treatment arms will be given the option to receive elective consolidation therapy of Paclitaxel 135 mg/m\^2 given every 28 days for one year. Patients not achieving a complete response will crossover to the opposite single agent.

Arms:
arm 1: Gemcitabine 1000 milligrams per meter square (mg/m\^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles arm 2: Paclitaxel 175 milligrams per meter square (mg/m\^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles

Interventions: intervention 1: Gemcitabine intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: 1000 mg/m\^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles

If anything other than complete response in Paclitaxel arm patients, 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity intervention 2: 175 mg/m\^2, IV, Day 1, q 21 days x 6 cycles

If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m\^2, IV, 3 hours q 28 days x 12 cycles (1 year)

If no complete response, then Gemcitabine arm patients may receive 175 mg/m\^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity intervention 3: Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles

Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles

Protocol document: