Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

OBJECTIVES:

Primary

- Determine the maximum tolerated dose of intraperitoneal carboplatin when administered
with paclitaxel during course 1, in patients with stage II-IV ovarian epithelial,
primary peritoneal, or fallopian tube cancer who had initial debulking surgery.

- Determine the feasibility of this regimen in these patients.

- Determine the feasibility of adding IV bevacizumab to this regimen in courses 2-6.

Secondary

- Determine the toxicity profile of this regimen in these patients.

- Determine the toxicity profile of paclitaxel and bevacizumab IV in combination with
intraperitoneal carboplatin in these patients.

- Determine the response rate (in patients with measurable disease who are in the
expanded cohort) and progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin.

Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15
minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV
over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional
20-40 patients are treated at that dose level.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for dose escalation and 20-40 for
feasibility) will be accrued for this study within 15 months.