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

Last updated: July 1, 2016
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

N/A

Condition

Colon Cancer

Bowel Dysfunction

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT00048971
CALGB-60102
CDR0000257145
NCCTG-CALGB-60102
CALGB-60102
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 308
Study Start date:
April 01, 2002
Estimated Completion Date:
November 30, 2006

Study 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.

Connect with a study center

  • McGill University

    Montreal, Quebec H2W 1S6
    Canada

    Site Not Available

  • University of Puerto Rico School of Medicine Medical Sciences Campus

    San Juan, 00936-5067
    Puerto Rico

    Site Not Available

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California 92093-0658
    United States

    Site Not Available

  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Diego

    San Diego, California 92161
    United States

    Site Not Available

  • UCSF Comprehensive Cancer Center

    San Francisco, California 94115
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California 94121
    United States

    Site Not Available

  • CCOP - Christiana Care Health Services

    Newark, Delaware 19713
    United States

    Site Not Available

  • Lombardi Cancer Center of Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Washington, DC

    Washington, District of Columbia 20422
    United States

    Site Not Available

  • Walter Reed Army Medical Center

    Washington, District of Columbia 20307-5000
    United States

    Site Not Available

  • Broward General Medical Center

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Memorial Regional Hospital Comprehensive Cancer Center

    Hollywood, Florida 33021
    United States

    Site Not Available

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Florida Hospital Cancer Institute

    Orlando, Florida 32804
    United States

    Site Not Available

  • Palm Beach Cancer Institute

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois 60640
    United States

    Site Not Available

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois 60612-7323
    United States

    Site Not Available

  • University of Chicago Cancer Research Center

    Chicago, Illinois 60637-1470
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois 60612
    United States

    Site Not Available

  • West Suburban Center for Cancer Care

    River Forest, Illinois 60305
    United States

    Site Not Available

  • Saint Anthony Medical Center

    Rockford, Illinois 61108
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology, Incorporated

    Fort Wayne, Indiana 46885-5099
    United States

    Site Not Available

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa 52242-1009
    United States

    Site Not Available

  • Baptist Hospital East - Louisville

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Baltimore

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Massachusetts Memorial Medical Center - University Campus

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Lakeland Medical Center - St. Joseph

    Saint Joseph, Michigan 49085
    United States

    Site Not Available

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri 65203
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Missouri Baptist Cancer Center

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198-7680
    United States

    Site Not Available

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Las Vegas

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Norris Cotton Cancer Center at Dartmouth Medical School

    Lebanon, New Hampshire 03756-0002
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263-0001
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York 14215
    United States

    Site Not Available

  • Elmhurst Hospital Center

    Elmhurst, New York 11373
    United States

    Site Not Available

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York 11432
    United States

    Site Not Available

  • CCOP - North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • Mount Sinai Medical Center, NY

    New York, New York 10029
    United States

    Site Not Available

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York 13217
    United States

    Site Not Available

  • State University of New York - Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York 13210
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Asheville

    Asheville, North Carolina 28805
    United States

    Site Not Available

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina 27599-7295
    United States

    Site Not Available

  • NorthEast Oncology Associates

    Concord, North Carolina 28025
    United States

    Site Not Available

  • Duke Comprehensive Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cape Fear Valley Health System

    Fayetteville, North Carolina 28302-2000
    United States

    Site Not Available

  • Lenoir Memorial Hospital Cancer Center

    Kinston, North Carolina 28503-1678
    United States

    Site Not Available

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina 28374
    United States

    Site Not Available

  • New Hanover Regional Medical Center

    Wilmington, North Carolina 28402-9025
    United States

    Site Not Available

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina 27104-4241
    United States

    Site Not Available

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina 27157-1082
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Fargo

    Fargo, North Dakota 58102
    United States

    Site Not Available

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania 17822-2001
    United States

    Site Not Available

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas

    Dallas, Texas 75235-9154
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas 75216
    United States

    Site Not Available

  • Green Mountain Oncology Group

    Bennington, Vermont 05201
    United States

    Site Not Available

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont 05401-3498
    United States

    Site Not Available

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont 05009
    United States

    Site Not Available

  • Martha Jefferson Hospital

    Charlottesville, Virginia 22902
    United States

    Site Not Available

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia 23298-0037
    United States

    Site Not Available

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • St. Mary's Medical Center

    Huntington, West Virginia 25701
    United States

    Site Not Available

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

  • Ministry Medical Group - Northern Region

    Rhinelander, Wisconsin 54501
    United States

    Site Not Available

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