S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
- Conditions
- Esophageal CancerGastric Cancer
- Interventions
- Registration Number
- NCT00004233
- 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. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and leucovorin in treating patients who have unresectable, locally advanced, or metastatic cancer of the esophagus or stomach.
- Detailed Description
OBJECTIVES:
* Assess the 6-month survival rate in patients with unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with triacetyluridine, fluorouracil, and leucovorin calcium.
* Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes beginning 1 hour into leucovorin calcium infusion on days 1, 8, 15, 22, 29, and 36. Patients receive oral triacetyluridine every 8 hours on days 1-3, 8-10, 15-17, 22-24, 29-31, and 36-38 beginning 8 hours after completion of each fluorouracil infusion. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 5-FU, Leucovorin and PN-401 leucovorin calcium PN401 is given on Days 1-3 weekly for six weeks; 5FU and leucovorin are given on Day 1 weekely for six weeks; followed by two weeks of rest. Continued in 8 week cycles until one of the criteria for removal from treatment is met. 5-FU, Leucovorin and PN-401 fluorouracil PN401 is given on Days 1-3 weekly for six weeks; 5FU and leucovorin are given on Day 1 weekely for six weeks; followed by two weeks of rest. Continued in 8 week cycles until one of the criteria for removal from treatment is met. 5-FU, Leucovorin and PN-401 triacetyluridine PN401 is given on Days 1-3 weekly for six weeks; 5FU and leucovorin are given on Day 1 weekely for six weeks; followed by two weeks of rest. Continued in 8 week cycles until one of the criteria for removal from treatment is met.
- Primary Outcome Measures
Name Time Method Six month survival six months after registration
- Secondary Outcome Measures
Name Time Method evaluate quantitative and qualitative toxicities three years at most
Trial Locations
- Locations (97)
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Veterans Affairs Medical Center - Albany
🇺🇸Albany, New York, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
St. Vincents Comprehensive Cancer Center
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles
🇺🇸Los Angeles, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
CCOP - Northwest
🇺🇸Tacoma, 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
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, 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
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States