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Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy Clinical research trials and Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy. Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy clinical trial. Subjects typically recieve the finest healthcare available for their Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy  Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
For Condition: adenocarcinoma of the colon,stage 3 colon cancer,Diarrhea,Neutropenia
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI),North Central Cancer Treatment Group
Synopsis: 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.
Details: 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. PROJECTED ACCRUAL: Approximately 308 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 Performance status - Not specified Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Not specified Renal - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkRatain, Study Chair, University of Chicago Cancer Research Center
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Lombardi Cancer Center of Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
Dallas, Texas, 75235-9154
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Siteman Cancer Center
St. Louis, Missouri, 63110
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
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
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05401-3498
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, 03756-0002
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
New York Weill Cornell Cancer Center at Cornell University
New York City, New York, 10021
United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Additional Information:
Study ID Numbers: CDR0000257145; NCCTG-CALGB-60102,CALGB-60102
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048971
Other Diarrhea Studies:
1. A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients with Acquired Immunodeficiency Related Diarrhea who were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.
2. Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer
3. Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
4. A phase II, randomized, open-label, controlled, dose-elevation, multicenter trial of an investigational drug for the prevention of diarrhea associated with Irinotecan/5FU/Leucovorin chemotherapy in patients with previously untreated metastatic colorectal cancer
5. Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
Related Studies:
Other Diarrhea Clinical Trials
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Other Fayetteville Clinical Trials
Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
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