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

NCT00048971 | Completed

• 3 other identifiers: CALGB-60102NCCTG-CALGB-60102CDR0000257145
• Study Type: observational
• Target: 308
• Locations: 3 countries
• Sites: 84

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.

Conditions

Colorectal Cancer; Diarrhea; Neutropenia

Keywords

adenocarcinoma of the colon; stage III colon cancer; diarrhea; neutropenia

Outcome Measures

Primary Outcomes (1)

• response

  Up to 4 years

Study Arms (1)

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.

Genetic: mutation analysis; Genetic: polymorphic microsatellite marker analysis

Interventions

mutation analysis GENETIC

Group 1

polymorphic microsatellite marker analysis GENETIC

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with adenocarcinoma of the colon and previously enrolled on CALGB-89803.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (84)

Northeast Alabama Regional Medical Center

Anniston, Alabama, 36207, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

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

Los Angeles, California, 90048, United States

Location

Veterans Affairs Medical Center - San Diego

San Diego, California, 92161, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Cancer Center of Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Veterans Affairs Medical Center - Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Memorial Regional Hospital Comprehensive Cancer Center

Hollywood, Florida, 33021, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Palm Beach Cancer Institute

West Palm Beach, Florida, 33401, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612-7323, United States

Location

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

West Suburban Center for Cancer Care

River Forest, Illinois, 60305, United States

Location

Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

Fort Wayne Medical Oncology and Hematology, Incorporated

Fort Wayne, Indiana, 46885-5099, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Baptist Hospital East - Louisville

Louisville, Kentucky, 40207, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Veterans Affairs Medical Center - Baltimore

Baltimore, Maryland, 21201, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Lakeland Medical Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Veterans Affairs Medical Center - Columbia (Truman Memorial)

Columbia, Missouri, 65201, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Veterans Affairs Medical Center - Las Vegas

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center at Dartmouth Medical School

Lebanon, New Hampshire, 03756-0002, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

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

Syracuse, New York, 13217, United States

Location

Veterans Affairs Medical Center - Asheville

Asheville, North Carolina, 28805, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

NorthEast Oncology Associates

Concord, North Carolina, 28025, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Cape Fear Valley Health System

Fayetteville, North Carolina, 28302-2000, United States

Location

Lenoir Memorial Hospital Cancer Center

Kinston, North Carolina, 28503-1678, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28402-9025, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Veterans Affairs Medical Center - Fargo

Fargo, North Dakota, 58102, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Lifespan: The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Veterans Affairs Medical Center - Dallas

Dallas, Texas, 75216, United States

Location

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

Dallas, Texas, 75235-9154, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05401-3498, United States

Location

Veterans Affairs Medical Center - White River Junction

White River Junction, Vermont, 05009, United States

Location

Martha Jefferson Hospital

Charlottesville, Virginia, 22902, United States

Location

Virginia Oncology Associates - Norfolk

Norfolk, Virginia, 23502, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25701, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Ministry Medical Group - Northern Region

Rhinelander, Wisconsin, 54501, United States

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, Puerto Rico, 00936-5067, Puerto Rico

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood specimens

MeSH Terms

Conditions

Colorectal Neoplasms; Diarrhea; Neutropenia; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Mark J. Ratain, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

CA (1); US (82); PR (1)