Spots Global Cancer Trial Database for Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
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Trial Identification
Brief Title: Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Official Title: A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma
Study ID: NCT00003691
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
Detailed Description: OBJECTIVES: * Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma. * Compare the toxicities of these two regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour. * Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days. Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 21 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
CCOP - Greater Phoenix, Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
Women's Cancer Center, Palo Alto, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Medicine Branch, Bethesda, Maryland, United States
Radiation Oncology Branch, Bethesda, Maryland, United States
Tufts University School of Medicine, Boston, Massachusetts, United States
Memorial Hospital, Worcester, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Cooper Hospital/University Medical Center, Camden, New Jersey, United States
Cancer Center of Albany Medical Center, Albany, New York, United States
State University of New York Health Science Center at Brooklyn, Brooklyn, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
CCOP - Sooner State, Tulsa, Oklahoma, United States
CCOP - Columbia River Program, Portland, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
CCOP - Baptist Cancer Institute, Memphis, Tennessee, United States
Brookview Research, Inc., Nashville, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Cancer Center, University of Virginia HSC, Charlottesville, Virginia, United States
University of Washington Medical Center, Seattle, Washington, United States
Tacoma General Hospital, Tacoma, Washington, United States
NCIC-Clinical Trials Group, Kingston, Ontario, Canada
Contact Details
Name: Gini F. Fleming, MD
Affiliation: University of Chicago
Role: STUDY_CHAIR
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