Conditions: Ovarian Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 149
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: pertuzumab intervention 2: paclitaxel intervention 3: gemcitabine intervention 4: carboplatin
Intervention descriptions: intervention 1: Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks intervention 2: 175 mg/m2 IV every 3 weeks for 6 cycles intervention 3: 1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles intervention 4: Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

Protocol document: