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

Ovarian Cancer Clinical Trial

— OCEANS  

Official title:

A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434642
• Other study ID #: AVF4095g
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2007
• Last updated: September 26, 2014
• Start date: April 2007
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This was a placebo-controlled, randomized, multicenter Phase III study that evaluated 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: July 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Ovarian Cancer

Intervention

Drug:
• Carboplatin
Carboplatin was provided as commercially available drug.
• Gemcitabine
Gemcitabine was provided as commercially available 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.
• Placebo
Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)	PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.	From randomization through September 17, 2010 (up to 3 years, 5 months)	No
Secondary	Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)	An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.	From randomization through September 17, 2010 (up to 3 years, 5 months)	No
Secondary	Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)	Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.	From randomization through September 17, 2010 (up to 3 years, 5 months)	No
Secondary	Overall Survival	Overall survival was defined as the time from randomization to death from any cause.	From randomization through July 19, 2013 (up to 6 years, 3 months)	No
Secondary	Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)	A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.	From randomization through September 17, 2010 (up to 3 years, 5 months)	Yes
Secondary	Percentage of Patients Who Had at Least 1 Adverse Event		From randomization through July 19, 2013 (up to 6 years, 3 months)	Yes