A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
MeSH terms: Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: Paclitaxel; Bevacizumab; Carboplatin; Placebo
Intervention description: 175 mg/m^2 IV infusion on Day 1 of each 21-day cycle.; 15 mg/kg IV infusion on Day 1 of each 21-day cycle.; Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle.; Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, double-blind, 2-arm, randomized study will evaluate the efficacy and safety
      of bevacizumab plus paclitaxel and caboplatin compared with placebo plus paclitaxel and
      caboplatin in Chinese participants with newly diagnosed, previously untreated Stage III or
      Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants whose
      disease has not progressed after six cycles of paclitaxel and carboplatin with either
      bevacizumab or placebo will continue treatment with either bevacizumab or placebo until
      disease progression, unacceptable toxicity, or a maximum of 22 cycles, whichever occurs
      first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC),
             peritoneal primary carcinoma, or fallopian tube cancer.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

          -  Life expectancy of at least 12 weeks.

          -  Adequate hematological, liver, renal and neurologic functions.

          -  For participants who receive therapeutic anticoagulation: stable anticoagulant
             regimen.

          -  Enrollment between 1 and 12 weeks after initial surgery is performed for the combined
             purpose of diagnosis, staging, and cytoreduction

        Exclusion Criteria:

          -  Current diagnosis of borderline epithelial ovarian tumor or recurrent invasive
             epithelial ovarian, primary peritoneal, or fallopian tube cancer treated with surgery
             only.

          -  Prior radiotherapy to any portion of the abdominal cavity or pelvis.

          -  Prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant
             chemotherapy for ovarian, primary peritoneal, or fallopian tube cancer.

          -  Any prior targeted therapy (including, but not limited to, vaccines, antibodies, or
             tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial
             ovarian or peritoneal primary cancer.

          -  Synchronous primary endometrial cancer.

          -  Have a prior history of primary endometrial cancer, except: Stage not greater than
             Stage IB; no more than superficial myometrial invasion, without vascular or lymphatic
             invasion; no poorly differentiated subtypes, including papillary serous, clear cell,
             or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions.

          -  Cancer present within the last 5 years with the exception of non-melanoma-related skin
             cancers and other specific malignancies or whose previous cancer treatment
             contraindicates study treatment.

          -  Active hepatitis B virus (HBV) infection (chronic or acute) or active hepatitis C
             virus (HCV) infection.

          -  Serious non-healing wounds, ulcers, or bone fractures.

          -  Patients with clinically significant cardiovascular disease.

          -  Have known hypersensitivity to Chinese hamster ovary cell products or other
             recombinant human or humanized antibodies.

          -  Have known sensitivity to any component of paclitaxel.

          -  Undergo major surgical procedure within 28 days prior to randomization or anticipated
             during the course of the study.

          -  Have core biopsy or other minor surgical procedures within 7 days prior to the first
             dose of bevacizumab/placebo.

          -  History or evidence of thrombotic disorders within the last 6 months prior to
             enrollment.