Conditions: Ovarian Cancer Stage IIIC Ovarian Cancer Stage IV
Keywords: Ovarian Cancer Stage IIIC Ovarian Cancer Stage IV CS-1008 Paclitaxel Carboplatin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: no

Brief summary:
This trial assessed the effect of treatment with CS-1008 in combination with paclitaxel/carboplatin on response in patients with locally advanced or metastatic ovarian cancer.

Detailed description:
This trial assessed CS-1008 administered in combination with paclitaxel/carboplatin to patients with Stage IIIC or IV ovarian cancer who had suboptimal debulking surgery with residual measurable/evaluable disease and who had not received prior therapy for their disease. The effect of this first-line treatment in patients was assessed by complete response rate.

Arms:
arm 1: CS-1008 will be administered with paclitaxel and carboplatin.

Interventions: intervention 1: CS-1008 intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: CS-1008 intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6 intervention 2: Paclitaxel 175 mg/m\^2 IV infusion once every 3 weeks (1 cycle) for 6 cycles intervention 3: Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) IV infusion once every 3 weeks (1 cycle) for 6 cycles

Protocol document: