A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Paclitaxel; Bevacizumab; Carboplatin
Intervention description: 175 mg/m^2 on Day 1 every 3 weeks or at a dose of 80 mg/m^2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first; 15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first; AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1021.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, non-comparative, multi-center study will assess the safety profile and
      efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in
      participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal
      carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously
      (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the
      plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of
      8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80
      mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108
      weeks or until disease progression or unacceptable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma,
             primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants
             with recurrent ovarian cancer who have been previously treated with surgery alone for
             their early stage disease are eligible.

          -  Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2

          -  Life expectancy greater than or equal to (>=3) months

        Exclusion Criteria:

          -  Participants with non-epithelial ovarian cancer, ovarian tumors with low malignant
             potential (i.e., borderline tumors), or synchronous primary endometrial carcinoma

          -  Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is
             allowed

          -  Planned intraperitoneal cytotoxic chemotherapy

          -  Radiotherapy within 28 days of Day 1, Cycle 1

          -  Major surgical procedure, open biopsy or significant traumatic injury within 28 days
             prior to first dose of Avastin

          -  History or evidence of National Cancer Institute Common Terminology Criteria for
             Adverse Events (NCI CTCAE) Grade >=1 arterial thromboembolic event or Grade >=3 venous
             thromboembolic event within 6 months prior to enrollment