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

NCT ID: NCT00434642

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2013-07-31

Brief Summary

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Carboplatin and gemcitabine + bevacizumab

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.

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

Carboplatin was provided as commercially available drug.

Gemcitabine

Intervention Type: DRUG

Gemcitabine was provided as commercially available drug.

Bevacizumab

Intervention Type: DRUG

Bevacizumab was supplied as a clear to slightly opalescent, sterile liquid in glass vials (400 mg in 8 mL \[25 mg/mL\]) with a vehicle consisting of sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Carboplatin and gemcitabine + placebo

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.

Group Type: ACTIVE_COMPARATOR

Carboplatin

Intervention Type: DRUG

Carboplatin was provided as commercially available drug.

Gemcitabine

Intervention Type: DRUG

Gemcitabine was provided as commercially available drug.

Placebo

Intervention Type: DRUG

Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Interventions

Carboplatin

Carboplatin was provided as commercially available drug.

Intervention Type: DRUG

Gemcitabine

Gemcitabine was provided as commercially available drug.

Intervention Type: DRUG

Bevacizumab

Bevacizumab was supplied as a clear to slightly opalescent, sterile liquid in glass vials (400 mg in 8 mL \[25 mg/mL\]) with a vehicle consisting of sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Intervention Type: DRUG

Placebo

Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Intervention Type: DRUG

Other Intervention Names

Avastin

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amreen Husain, MD

Role: STUDY_DIRECTOR

Genentech, Inc.

References

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Reference Type: DERIVED

PMID: 37185961 (View on PubMed)

Aghajanian C, Goff B, Nycum LR, Wang YV, Husain A, Blank SV. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol. 2015 Oct;139(1):10-6. doi: 10.1016/j.ygyno.2015.08.004. Epub 2015 Aug 10.

Reference Type: DERIVED

PMID: 26271155 (View on PubMed)

Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.

Reference Type: DERIVED

PMID: 21941283 (View on PubMed)

Other Identifiers

AVF4095g

Identifier Type: -

Identifier Source: org_study_id