Conditions: Ovarian Cancer Primary Peritoneal Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 86
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer.

Detailed description:

Arms:
arm 1: Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. arm 2: Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Interventions: intervention 1: Pemetrexed - Phase 1 intervention 2: Carboplatin - Phase 1 intervention 3: Pemetrexed - Phase 2 intervention 4: Carboplatin - Phase 2
Intervention descriptions: intervention 1: 500, 600, 700, 800, or 900 milligrams per square meter (mg/m\^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD) intervention 2: area under the concentration time curve (AUC) 5 or 6 mg/mL\*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD) intervention 3: Dose determined from Phase 1: 500 mg/m\^2, administered IV, every 21 days x 6 cycles intervention 4: Dose determined from Phase 1: AUC 6 mg/mL\*min, administered IV, every 21 days x 6 cycles

Protocol document: