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
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) as assessed by CTC version 2.0 during the first course of therapy
Mark A. Morgan, MD, FACOG, FACS
Fox Chase Cancer Center
United States: Federal Government
|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|