A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01239732

2010-019525-34 (EudraCT Number)

MO22923

Details and patient eligibility

About

This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80 mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

Enrollment: 1,021 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
• Life expectancy greater than or equal to (>=3) months

Exclusion criteria

• Participants with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e., borderline tumors), or synchronous primary endometrial carcinoma
• Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
• Planned intraperitoneal cytotoxic chemotherapy
• Radiotherapy within 28 days of Day 1, Cycle 1
• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
• History or evidence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=1 arterial thromboembolic event or Grade >=3 venous thromboembolic event within 6 months prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,021 participants in 1 patient group

Bevacizumab + Paclitaxel + Carboplatin

Experimental group

Description:

Participants will receive bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol defined disease progression or until unacceptable toxicity (whichever occurred first). Participants will receive paclitaxel 175 mg/m\^2 IV on Day 1 every 3 weeks or 80 mg/m\^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol defined disease progression, or unacceptable toxicity (whichever occurred first).

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Bevacizumab