A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma
Condition: Ovarian Cancer
MeSH terms: Carcinoma
Intervention: Carboplatin; Gemcitabine; Bevacizumab; Placebo
Intervention description: Carboplatin was provided as commercially available drug.; Gemcitabine was provided as commercially available 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.; Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.
Intervention MeSH terms: Bevacizumab; Carboplatin; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 484.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Avastin; Ovarian carcinoma; Peritoneal carcinoma; Peritoneal cancer; Fallopian tube cancer; Fallopian tube carcinoma; OCEANS

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.
    

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)