Trial Information

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

A Phase II, 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

Patient Inclusion Criteria:

• Signed Informed Consent Form
• Age = 18 years
• Histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that has progressed or recurred > 6 months after platinum-based chemotherapy
• This must be the first recurrence of epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
• No prior chemotherapy in the recurrent setting
• Measurable disease according to RECIST with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded)
• Each measurable lesion must be 20 mm when measured by conventional techniques, CT and MRI, or 10 mm when measured by spiral CT.
• Greater than 28 days from and recovered from prior radiation therapy or surgery ECOG performance status 0 or 1
• Use of an effective means of contraception (for women of childbearing potential)
• Ability to comply with study and follow-up procedures

Patient Exclusion Criteria:

• Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma.
• History of abdominal fistula, GIP, or intra-abdominal abscess
• Patients with clinical symptoms or signs of 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
• Life expectancy of < 12 weeks
• Current, recent (within 4 weeks of Day 1, Cycle 1), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
• Screening clinical laboratory values: Granulocyte count < 1500/uL; Platelet count < 100,000/uL; Hemoglobin < 8.5 g/dL; Serum bilirubin > 2.0 x upper limits of normal (ULN); Alkaline phosphatase, aspartate transaminase (AST), and alanine transaminase (ALT) > 2.5 x ULN (AST, ALT > 5 x ULN for patients with liver metastasis); Serum creatinine = 1.6; International normalized ratio (INR) > 1.5 and activated partial thromboplastin time (aPTT) > 1.5 x ULN (except for patients receiving anticoagulation therapy)
• History of other malignancies within 5 years of Day 1, Cycle 1, except for adequately-treated carcinoma in situ of the cervix, ductal carcinoma in situ of breast, or basal or squamous cell skin cancer
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications
• History of bevacizumab (Avastin(R)) or other VEGF or VEGF receptor-targeted agent use
• Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association Class II or greater CHF
• History of myocardial infarction or unstable angina within 6 months prior to Day 1, Cycle 1 (day of the first bevacizumab/placebo infusion)
• History of stroke or transient ischemic attack (TIA) within 6 months prior to study enrollment
• Known CNS disease except for treated brain metastasis
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1, Cycle 1
• History of hemoptysis (= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1, Cycle 1
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, Cycle 1 or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1, Cycle 1
• Serious, non-healing wound; active ulcer; or untreated bone fracture
• Proteinuria at screening, as demonstrated by a UPCR of = 1.0 at screening
• Known hypersensitivity to any component of bevacizumab
• Pregnancy (positive pregnancy test) or lactation
• Current, ongoing treatment with full-dose warfarin

If you would like to learn more about participating in this study, please send an e-mail message using the form below.