Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus
- Conditions
- Sarcoma
- Registration Number
- NCT00003128
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide alone is more effective than ifosfamide plus paclitaxel in treating patients with cancer of the uterus.
PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with or without paclitaxel in treating patients with advanced, refractory, or recurrent cancer of the uterus.
- Detailed Description
OBJECTIVES:
* Determine whether the addition of paclitaxel to ifosfamide improves length of survival, progression free interval and response rate when compared to ifosfamide alone in patients with advanced, refractory or recurrent carcinosarcoma (mixed mesodermal tumors) of the uterus.
* Determine the toxicity of ifosfamide with paclitaxel in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to GOG performance status (GOG 0-1 vs GOG 2-3) and randomized to one of two treatment arms.
* Arm I: Patients receive ifosfamide IV daily for 3 days every 21 days.
* Arm II: Patients receive paclitaxel IV on day 1 and ifosfamide IV on days 1-3 every 21 days. Filgrastim (G-CSF) is given subcutaneously beginning on day 4 until granulocyte count is greater than 2,000/mm3. Paclitaxel therapy may precede or be given concurrently with ifosfamide.
Treatment for both arms continues for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, then every 6 months for an additional 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 166 patients (83 per arm) will be accrued for this study within approximately 5.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 166
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Norris Cotton Cancer Center at Dartmouth Medical School
🇺🇸Lebanon, New Hampshire, United States
MBCCOP-Our Lady of Mercy Cancer Center
🇺🇸Bronx, New York, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States