Spots Global Cancer Trial Database for Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus
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Trial Identification
Brief Title: Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus
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 ID: NCT00003128
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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 - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Tufts - New England Medical Center, Boston, Massachusetts, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 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
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Contact Details
Name: Howard D. Homesley, MD
Affiliation: Gynecologic Oncology Network
Role: STUDY_CHAIR
Name: Higinia R. Cardenes, MD, PhD
Affiliation: Indiana University Melvin and Bren Simon Cancer Center
Role: STUDY_CHAIR
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