Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
- Conditions
- Colorectal CancerDiarrheaNeutropenia
- Interventions
- Genetic: mutation analysisGenetic: polymorphic microsatellite marker analysis
- Registration Number
- NCT00048971
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects.
PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy.
- Detailed Description
OBJECTIVES:
* Determine whether the presence of a 7 allele at the UGT1A1 locus is associated with either grade 3-4 diarrhea or grade 4 neutropenia in patients with stage III colon cancer after treatment with irinotecan, fluorouracil, and leucovorin calcium.
* Determine whether polymorphisms in the TS enhancer and/or MTHFR gene are associated with grade 3-4 diarrhea in these patients after treatment with fluorouracil and leucovorin calcium.
* Determine whether polymorphisms in UGT1A1, TS, MTHFR, CYP3A4, or CYP3A5 are associated with either grade 3-4 diarrhea or grade 4 neutropenia in these patients after treatment with irinotecan, fluorouracil, and leucovorin calcium.
OUTLINE: Patients are stratified according to prior therapy (irinotecan, fluorouracil, and leucovorin calcium vs fluorouracil and leucovorin calcium) and prior toxic effects (grade 3-4 diarrhea vs grade 4 neutropenia vs grade 1 or lower diarrhea AND grade 2 or lower neutropenia).
Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis. Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 308
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 mutation analysis Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis. Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms. Group 1 polymorphic microsatellite marker analysis Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis. Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms.
- Primary Outcome Measures
Name Time Method response Up to 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (84)
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Lombardi Cancer Center of Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Memorial Regional Hospital Comprehensive Cancer Center
🇺🇸Hollywood, Florida, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Veterans Affairs Medical Center - Baltimore
🇺🇸Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Lakeland Medical Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Norris Cotton Cancer Center at Dartmouth Medical School
🇺🇸Lebanon, New Hampshire, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
NorthEast Oncology Associates
🇺🇸Concord, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
🇺🇸Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
🇺🇸Dallas, Texas, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
McGill University
🇨🇦Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Ministry Medical Group - Northern Region
🇺🇸Rhinelander, Wisconsin, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States