Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase III Trial of Ifosfamide (NSC #109274) Versus Ifosfamide Plus Paclitaxel (NSC #125973) in Patients With Advanced, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus|
|Study Start Date:||November 1997|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003128
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, California|
|Stanford Cancer Center at Stanford University Medical Center|
|Stanford, California, United States, 94305-5216|
|United States, Illinois|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|CCOP - Northern Indiana CR Consortium|
|South Bend, Indiana, United States, 46601|
|United States, Louisiana|
|CCOP - Ochsner|
|New Orleans, Louisiana, United States, 70121|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|United States, Massachusetts|
|Tufts - New England Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Nevada|
|CCOP - Southern Nevada Cancer Research Foundation|
|Las Vegas, Nevada, United States, 89106|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth Medical School|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, New York|
|MBCCOP-Our Lady of Mercy Cancer Center|
|Bronx, New York, United States, 10466|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|CCOP - Geisinger Clinic and Medical Center|
|Danville, Pennsylvania, United States, 17822-2001|
|Abramson Cancer Center at University of Pennsylvania Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|United States, Texas|
|CCOP - Scott and White Hospital|
|Temple, Texas, United States, 76508|
|Study Chair:||Howard D. Homesley, MD||Gynecologic Oncology Network|
|Study Chair:||Higinia R. Cardenes, MD, PhD||Indiana University Melvin and Bren Simon Cancer Center|