Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
RATIONALE: Drugs used in chemotherapy such as polyglutamate paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of polyglutamate paclitaxel when given together with carboplatin in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: paclitaxel poliglumex
Procedure: adjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum tolerated dose (MTD) as assessed by CTC version 2.0 during the first course of therapy [ Designated as safety issue: Yes ]
- Feasibility as assessed by CTC version 2.0 weekly during treatment for up to 8 courses [ Designated as safety issue: No ]
- Response rates as measured by RECIST criteria after courses 4 and 8 [ Designated as safety issue: No ]
- Pharmacokinetics as assessed by serum and urine measurements during courses 1-4 [ Designated as safety issue: No ]
|Study Start Date:||April 2003|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060359
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, New Jersey|
|Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees|
|Camden, New Jersey, United States, 08103|
|United States, Ohio|
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210|
|Hillcrest Cancer Center at Hillcrest Hospital|
|Mayfield Heights, Ohio, United States, 44124|
|Lake/University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|United States, Oklahoma|
|Oklahoma University Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Midtown Tulsa|
|Tulsa, Oklahoma, United States, 74104|
|United States, Pennsylvania|
|Fox Chase-Temple Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98104|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Study Chair:||Mark A. Morgan, MD, FACOG, FACS||Fox Chase Cancer Center|