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, IND #7921) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
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.
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of intraperitoneal carboplatin with intravenous paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Gynecologic Oncology Group
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|University of Washington Medical Center||Seattle, Washington 98195-6043|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|
|Pacific Gynecology Specialists||Seattle, Washington 98104|
|Riverside Methodist Hospital||Columbus, Ohio 43214|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|M D Anderson Cancer Center||Houston, Texas 77030|
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|
|Cooper Hospital University Medical Center||Camden, New Jersey 08103|
|University of California Medical Center At Irvine-Orange Campus||Orange, California 92868|
|Cancer Care Associates-Yale||Tulsa, Oklahoma 74136-1929|
|Cancer Care Associates-Midtown||Tulsa, Oklahoma 74104|
|Women and Infants Hospital||Providence, Rhode Island 02905|
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|