A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00937560

MO22225

2008-008336-85 (EudraCT Number)

Details and patient eligibility

About

This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.

Enrollment: 190 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Female patients, ≥ 18 years of age.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Initial surgery, but no chemotherapy or radiotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria

• Non-epithelial tumors.
• Ovarian tumors with low malignant potential.
• Previous systemic anti-cancer therapy for ovarian cancer.
• History or evidence of synchronous primary endometrial cancer.
• Current or recent daily treatment with aspirin (> 325mg/day) or with full dose anticoagulant or thrombolytic agents for therapeutic purposes.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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190 participants in 1 patient group

Bevacizumab + paclitaxel + carboplatin

Experimental group

Description:

Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[glomerular filtration rate + 25\] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Bevacizumab