Spots Global Cancer Trial Database for S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer
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Trial Identification
Brief Title: S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer
Official Title: A Phase II Trial of Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Study ID: NCT00003549
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. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
MBCCOP - University of South Alabama, Mobile, Alabama, United States
CCOP - Greater Phoenix, Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, 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
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Beckman Research Institute, City of Hope, Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
University of California Davis Medical Center, Sacramento, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
University of Colorado Cancer Center, Denver, Colorado, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
CCOP - Central Illinois, Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, 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
Tulane University School of Medicine, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans, 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
Boston Medical Center, Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts, 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
CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
Providence Hospital - Southfield, Southfield, Michigan, United States
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Kettering, Ohio, 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 - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Texas Tech University Health Science Center, Lubbock, Texas, 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 - Temple, Temple, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Swedish Cancer Institute, Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
Contact Details
Name: Raymond A. Kempf, MD
Affiliation: University of Southern California
Role: STUDY_CHAIR
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