A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma (OCEANS)

Genentech

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Placebo; Drug: Carboplatin; Drug: Bevacizumab; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434642

AVF4095g

Details and patient eligibility

About

This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

Enrollment: 484 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed Consent Form
• Age ≥ 18 years
• Documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred
• No prior chemotherapy in the recurrent setting
• Measurable disease
• Recovered from prior radiation therapy or surgery

Exclusion criteria

• Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma
• History of abdominal fistula, gastrointestinal perforation (GIP), or intra-abdominal abscess
• Patients with clinical symptoms or signs of gastrointestinal (GI) obstruction or who require parenteral hydration, parenteral nutrition, or tube feeding
• Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
• Current, recent, or planned participation in an experimental drug study
• History of systemic bevacizumab (Avastin) or other vascular endothelial growth factor (VEGF) or VEGF receptor-targeted agent use
• Inadequately controlled hypertension
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association Class II or greater congestive heart failure (CHF)
• History of myocardial infarction or unstable angina
• History of stroke or transient ischemic attack (TIA)
• Known central nervous system (CNS) disease except for treated brain metastasis
• Significant vascular disease or recent peripheral arterial thrombosis
• History of hemoptysis
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

484 participants in 2 patient groups

Carboplatin and gemcitabine + bevacizumab

Experimental group

Description:

Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.

Treatment:

Drug: Bevacizumab

Drug: Carboplatin

Drug: Gemcitabine

Carboplatin and gemcitabine + placebo

Active Comparator group

Description:

Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.

Treatment:

Drug: Placebo

Drug: Carboplatin

Drug: Gemcitabine