Conditions: Ovarian Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 170
Healthy volunteers: no

Brief summary:
This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (\<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.

Detailed description:

Arms:
arm 1: Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. arm 2: AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.

Interventions: intervention 1: AMG 479 intervention 2: AMG 479 Placebo
Intervention descriptions: intervention 1: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle intervention 2: Matching placebo administered Day 1 of each 21 day cycle.

Protocol document: