An Expanded Cohort Phase I Study Of CT-2103 (IND #61013) And Carboplatin In Patients With Previously Untreated Epithelial Ovarian Carcinoma Or Primary Peritoneal Carcinoma
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of polyglutamate paclitaxel in combination
with carboplatin in patients with chemotherapy-naïve ovarian epithelial, primary
peritoneal, or fallopian tube carcinoma.
- Determine the feasibility of this regimen at the MTD in an expanded cohort of patients.
- Determine the response rate and progression-free survival of patients treated with this
regimen in the expanded cohort.
- Determine the toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug combination in these
patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study of polyglutamate
paclitaxel (CT-2103) followed by a feasibility, multicenter study.
- Dose-escalation phase: Patients receive CT-2103 IV over 10 minutes and carboplatin IV
over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CT-2103 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 during the first course of treatment.
- Feasibility phase: Once the MTD of CT-2103 is determined, an additional 20-40 patients
receive treatment at that dose level combined with carboplatin as above.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for dose-escalation phase and 20-40 for
feasibility phase) will be accrued for this study within 4-10 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) as assessed by CTC version 2.0 during the first course of therapy
Yes
Mark A. Morgan, MD, FACOG, FACS
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000301642
NCT00060359
April 2003
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Fox Chase-Temple Cancer Center | Philadelphia, Pennsylvania 19111-2442 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden, New Jersey 08103 |