S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer
- Conditions
- Neuroendocrine Carcinoma of the Skin
- Registration Number
- NCT00003549
- 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 combining cyclophosphamide, methotrexate, and fluorouracil in treating patients with Merkel cell cancer.
- Detailed Description
OBJECTIVES: I. Investigate the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with unresectable Merkel cell carcinoma that is local-regional or metastatic. II. Determine the overall survival rate and objective response rate of these patients after treatment with cyclophosphamide, methotrexate, and fluorouracil.
OUTLINE: Patients are stratified according to local-regional disease versus metastatic disease. Patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicities. Patients are followed every 6 months for 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 80 patients (40 patients per stratum) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (84)
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, 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
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States