Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
NCT ID: NCT00048971
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
308 participants
OBSERVATIONAL
2002-04-30
2006-11-30
Brief Summary
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PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group 1
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.
mutation analysis
polymorphic microsatellite marker analysis
Interventions
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mutation analysis
polymorphic microsatellite marker analysis
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed stage III adenocarcinoma of the colon
* Enrolled on CALGB-89803 and must fall into 1 of the following categories:
* Received irinotecan, fluorouracil, and leucovorin calcium and experienced at least 1 of the following:
* Grade 3-4 diarrhea
* Grade 4 neutropenia
* Grade 1 or lower diarrhea AND grade 2 or lower neutropenia
* Received fluorouracil and leucovorin calcium and experienced at least 1 of the following:
* Grade 3-4 diarrhea
* Grade 1 or lower diarrhea AND grade 2 or lower neutropenia
PATIENT CHARACTERISTICS:
Age
* 18 and over
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Mark J. Ratain, MD
Role: STUDY_CHAIR
University of Chicago
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center of Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Palm Beach Cancer Institute
West Palm 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
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Saint Anthony Medical Center
Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, 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
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 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
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 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
Barnes-Jewish Hospital
St Louis, Missouri, United States
Siteman Cancer Center
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 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
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, 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
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 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
Green Mountain Oncology Group
Bennington, Vermont, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, United States
McGill University
Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, Puerto Rico
Countries
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Other Identifiers
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CALGB-60102
Identifier Type: -
Identifier Source: secondary_id
NCCTG-CALGB-60102
Identifier Type: -
Identifier Source: secondary_id
CDR0000257145
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-60102
Identifier Type: -
Identifier Source: org_study_id
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