A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: gemcitabine; Drug: carboplatin; Drug: pertuzumab; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02004093

BO17931

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
• only 1 previous regimen, which must be platinum-based;
• platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.

Exclusion criteria

• previous radiotherapy;
• previous treatment with an anti-cancer vaccine or any targeted therapy;
• major surgery or traumatic injury within 4 weeks of study;
• history or evidence of central nervous system metastases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 2 patient groups

Chemotherapy + Pertuzumab

Experimental group

Treatment:

Drug: carboplatin

Drug: paclitaxel

Drug: gemcitabine

Drug: pertuzumab

Chemotherapy

Active Comparator group

Treatment:

Drug: carboplatin

Drug: paclitaxel

Drug: gemcitabine