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

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Trial Identification

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

Official Title: A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin

Study ID: NCT00048971

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, District of Columbia, 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

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, Saint Louis, Missouri, United States

Siteman Cancer Center, Saint Louis, Missouri, United States

Missouri Baptist Cancer Center, Saint 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

Contact Details

Name: Mark J. Ratain, MD

Affiliation: University of Chicago

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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