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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Howard D. Homesley, MD
Gynecologic Oncology Network
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|CCOP - Southern Nevada Cancer Research Foundation||Las Vegas, Nevada 89106|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Tufts - New England Medical Center||Boston, Massachusetts 02111|
|Stanford Cancer Center at Stanford University Medical Center||Stanford, California 94305|
|Norris Cotton Cancer Center at Dartmouth Medical School||Lebanon, New Hampshire 03756-0002|
|MBCCOP-Our Lady of Mercy Cancer Center||Bronx, New York 10466|
|Abramson Cancer Center at University of Pennsylvania Medical Center||Philadelphia, Pennsylvania 19104|