Colorectal CancerNCT00048971
Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
An observational study of Colorectal Cancer and Diarrhea, run by Alliance for Clinical Trials in Oncology at 84 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Diarrhea, Neutropenia
- What is being tested?
- mutation analysis and polymorphic microsatellite marker analysis
- How many people
- 308 participants
- Where
- 84 sitesin 3 countries
- Study dates
- Apr 2002to Nov 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
84 sites in 3 countries.
84 sites in 3 countries
United States82 sites
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
Green Mountain Oncology Group
Bennington, Vermont, 05201
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05401-3498
Cooper University Hospital
Camden, New Jersey, 08103
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
NorthEast Oncology Associates
Concord, North Carolina, 28025
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
Dallas, Texas, 75235-9154
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Elmhurst Hospital Center
Elmhurst, New York, 11373
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, 46885-5099
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
St. Mary's Medical Center
Huntington, West Virginia, 25701
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, 03756-0002
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, 90048
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
CCOP - North Shore University Hospital
Manhasset, New York, 11030
North Shore University Hospital
Manhasset, New York, 11030
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
Mount Sinai Medical Center, NY
New York, New York, 10029
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Florida Hospital Cancer Institute
Orlando, Florida, 32804
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
Saint Anthony Medical Center
Rockford, Illinois, 61108
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Siteman Cancer Center
St Louis, Missouri, 63110
Missouri Baptist Cancer Center
St Louis, Missouri, 63131
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
Lombardi Cancer Center of Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
Puerto Rico1 site
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
About this study
Official title: A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin
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.
Read the 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.
- Conditions
- Colorectal Cancer, Diarrhea, Neutropenia
- Being tested
- mutation analysis, polymorphic microsatellite marker analysis
- Keywords
- adenocarcinoma of the colon, stage III colon cancer, diarrhea, neutropenia
- Medical subject headings
- Colorectal Neoplasms, Diarrhea, Neutropenia, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutation analysisGenetic
polymorphic microsatellite marker analysisGenetic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: mutation analysis; Genetic: polymorphic microsatellite marker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
response
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2002
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark J. Ratain, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048971
- Sponsor's protocol ID
- CALGB-60102
- Other IDs
- CALGB-60102, NCCTG-CALGB-60102, CDR0000257145
- Status last verified
- Jul 2016
- First submitted
- 12 Nov 2002
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin
- ClinicalTrials.gov ID
- NCT00048971
- Acronym / sponsor ID
- CALGB-60102
- Conditions
- Colorectal Cancer, Diarrhea, Neutropenia
- Keywords
- adenocarcinoma of the colon, stage III colon cancer, diarrhea, neutropenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2002
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: mutation analysis, Genetic: polymorphic microsatellite marker analysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with adenocarcinoma of the colon and previously enrolled on CALGB-89803.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mutation analysis | Genetic | Group 1 |
| polymorphic microsatellite marker analysis | Genetic | Group 1 |
Primary outcome
response
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J. Ratain, MD study chair
University of Chicago
84 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Diarrhea, run by Alliance for Clinical Trials in Oncology at 84 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.