Fallopian Tube Cancer Clinical Trial
Official title:
A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin (NSC #214240) and Intravenous Paclitaxel (NSC # 673089) and Intravenous Paclitaxel, Intraperitoneal Carboplatin and NCI Supplied Intravenous Bevacizumab (NSC #704865) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating patients who have undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin and paclitaxel in treating ovarian epithelial or primary peritoneal cancer, or fallopian tube cancer.
PRIMARY OBJECTIVES:
I. 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.
II. Determine the feasibility of this regimen in these patients. III. Determine the
feasibility of adding IV bevacizumab to this regimen in courses 2-6.
SECONDARY OBJECTIVES:
I. Determine the toxicity profile of this regimen in these patients. II. Determine the
toxicity profile of paclitaxel and bevacizumab IV in combination with intraperitoneal
carboplatin in these patients.
III. 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.
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