S9720 Combination Chemotherapy in Treating Patients With Metastatic, Recurrent, or Refractory Endometrial Cancer
- Conditions
- Endometrial Cancer
- Interventions
- Registration Number
- NCT00003127
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic, recurrent, or refractory endometrial cancer.
- Detailed Description
OBJECTIVES: I. Evaluate the efficacy of paclitaxel and carboplatin with amifostine on progression free survival and overall survival in patients with metastatic or recurrent epithelial endometrial carcinoma not amenable to surgery or radiotherapy. II. Evaluate response (confirmed and unconfirmed partial response and complete response) rate to this regimen in this patient population. III. Assess the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 3 hours, then amifostine IV over 10 minutes, followed fifteen minutes later by carboplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days. Treatment continues for 6 courses in the absence of disease progression. Patients are followed every 6 months for 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 35 to 50 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description carbo, taxol, amifostine amifostine trihydrate carbo, taxol, amifostine carbo, taxol, amifostine carboplatin carbo, taxol, amifostine carbo, taxol, amifostine paclitaxel carbo, taxol, amifostine
- Primary Outcome Measures
Name Time Method Progression free survival 6 months from date of registration to date of first observation of progressive disease, deathe due to any cause, or early discontinuation of treatment.
- Secondary Outcome Measures
Name Time Method overall survival 6 months From date of registration to date of death due to any cause
response after 12 and 24 weeks Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No disease progression. No new lesions.
toxicity Weekly X 3, q 4 weeks X 6 cycles assessment per SWOG toxicity criteria
Trial Locations
- Locations (94)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Cancer Center at Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States