Colon Cancer Clinical Trial

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Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy

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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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

Study is for people with:

Colon Cancer

Estimated Enrollment:

308

Study ID:

NCT00048971

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 77 Locations for this study

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Northeast Alabama Regional Medical Center
Anniston Alabama, 36207, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92093, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Veterans Affairs Medical Center - San Diego
San Diego California, 92161, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States
Veterans Affairs Medical Center - San Francisco
San Francisco California, 94121, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Lombardi Cancer Center of Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Veterans Affairs Medical Center - Washington, DC
Washington District of Columbia, 20422, United States
Broward General Medical Center
Fort Lauderdale Florida, 33316, United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood Florida, 33021, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
Palm Beach Cancer Institute
West Palm Beach Florida, 33401, United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Louis A. Weiss Memorial Hospital
Chicago Illinois, 60640, United States
West Suburban Center for Cancer Care
River Forest Illinois, 60305, United States
Saint Anthony Medical Center
Rockford Illinois, 61108, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne Indiana, 46885, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Baptist Hospital East - Louisville
Louisville Kentucky, 40207, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Veterans Affairs Medical Center - Baltimore
Baltimore Maryland, 21201, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester Massachusetts, 01655, United States
Lakeland Medical Center - St. Joseph
Saint Joseph Michigan, 49085, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia Missouri, 65201, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Siteman Cancer Center
Saint Louis Missouri, 63110, United States
Missouri Baptist Cancer Center
Saint Louis Missouri, 63131, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon New Hampshire, 03756, United States
Cooper University Hospital
Camden New Jersey, 08103, United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York, 14215, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Elmhurst Hospital Center
Elmhurst New York, 11373, United States
Queens Cancer Center of Queens Hospital
Jamaica New York, 11432, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Weill Cornell Cancer Center at Cornell University
New York New York, 10021, United States
Mount Sinai Medical Center, NY
New York New York, 10029, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York, 13210, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13217, United States
Veterans Affairs Medical Center - Asheville
Asheville North Carolina, 28805, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
NorthEast Oncology Associates
Concord North Carolina, 28025, United States
Veterans Affairs Medical Center - Durham
Durham North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Cape Fear Valley Health System
Fayetteville North Carolina, 28302, United States
Lenoir Memorial Hospital Cancer Center
Kinston North Carolina, 28503, United States
FirstHealth Moore Regional Hospital
Pinehurst North Carolina, 28374, United States
New Hanover Regional Medical Center
Wilmington North Carolina, 28402, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Veterans Affairs Medical Center - Fargo
Fargo North Dakota, 58102, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
Western Pennsylvania Hospital
Pittsburgh Pennsylvania, 15224, United States
Lifespan: The Miriam Hospital
Providence Rhode Island, 02906, United States
Veterans Affairs Medical Center - Dallas
Dallas Texas, 75216, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
Dallas Texas, 75235, United States
Green Mountain Oncology Group
Bennington Vermont, 05201, United States
Vermont Cancer Center at University of Vermont
Burlington Vermont, 05401, United States
Veterans Affairs Medical Center - White River Junction
White River Junction Vermont, 05009, United States
Martha Jefferson Hospital
Charlottesville Virginia, 22902, United States
Virginia Oncology Associates - Norfolk
Norfolk Virginia, 23502, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke Virginia, 24014, United States
St. Mary's Medical Center
Huntington West Virginia, 25701, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin, 54301, United States
Ministry Medical Group - Northern Region
Rhinelander Wisconsin, 54501, United States
McGill University
Montreal Quebec, H2W 1, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan , 00936, Puerto Rico
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How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

308

Study ID:

NCT00048971

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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