Clincosm LogoSign in Get a demo

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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00048971
Collaborator
National Cancer Institute (NCI) (NIH)
308
Enrollment
84
Locations
55
Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: mutation analysis
  • Genetic: polymorphic microsatellite marker analysis

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

Study Type:
Observational
Actual Enrollment :
308 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin
Study Start Date :
Apr 1, 2002
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. response [Up to 4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northeast Alabama Regional Medical Center Anniston Alabama United States 36207
2 Rebecca and John Moores UCSD Cancer Center La Jolla California United States 92093-0658
3 Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles California United States 90048
4 Veterans Affairs Medical Center - San Diego San Diego California United States 92161
5 UCSF Comprehensive Cancer Center San Francisco California United States 94115
6 Veterans Affairs Medical Center - San Francisco San Francisco California United States 94121
7 CCOP - Christiana Care Health Services Newark Delaware United States 19713
8 Lombardi Cancer Center of Georgetown University Medical Center Washington District of Columbia United States 20007
9 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
10 Veterans Affairs Medical Center - Washington, DC Washington District of Columbia United States 20422
11 Broward General Medical Center Fort Lauderdale Florida United States 33316
12 Memorial Regional Hospital Comprehensive Cancer Center Hollywood Florida United States 33021
13 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
14 Florida Hospital Cancer Institute Orlando Florida United States 32804
15 Palm Beach Cancer Institute West Palm Beach Florida United States 33401
16 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
17 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
18 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
19 Louis A. Weiss Memorial Hospital Chicago Illinois United States 60640
20 West Suburban Center for Cancer Care River Forest Illinois United States 60305
21 Saint Anthony Medical Center Rockford Illinois United States 61108
22 Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne Indiana United States 46885-5099
23 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
24 Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa United States 52242-1009
25 Baptist Hospital East - Louisville Louisville Kentucky United States 40207
26 Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
27 Veterans Affairs Medical Center - Baltimore Baltimore Maryland United States 21201
28 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts United States 02115
29 University of Massachusetts Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
30 Lakeland Medical Center - St. Joseph Saint Joseph Michigan United States 49085
31 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417
32 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
33 Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri United States 65201
34 Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri United States 65203
35 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
36 Siteman Cancer Center Saint Louis Missouri United States 63110
37 Missouri Baptist Cancer Center Saint Louis Missouri United States 63131
38 University of Nebraska Medical Center Omaha Nebraska United States 68198-7680
39 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
40 Veterans Affairs Medical Center - Las Vegas Las Vegas Nevada United States 89106
41 Norris Cotton Cancer Center at Dartmouth Medical School Lebanon New Hampshire United States 03756-0002
42 Cooper University Hospital Camden New Jersey United States 08103
43 Veterans Affairs Medical Center - Buffalo Buffalo New York United States 14215
44 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
45 Elmhurst Hospital Center Elmhurst New York United States 11373
46 Queens Cancer Center of Queens Hospital Jamaica New York United States 11432
47 CCOP - North Shore University Hospital Manhasset New York United States 11030
48 North Shore University Hospital Manhasset New York United States 11030
49 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
50 New York Weill Cornell Cancer Center at Cornell University New York New York United States 10021
51 Mount Sinai Medical Center, NY New York New York United States 10029
52 State University of New York - Upstate Medical University Syracuse New York United States 13210
53 Veterans Affairs Medical Center - Syracuse Syracuse New York United States 13210
54 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13217
55 Veterans Affairs Medical Center - Asheville Asheville North Carolina United States 28805
56 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
57 NorthEast Oncology Associates Concord North Carolina United States 28025
58 Veterans Affairs Medical Center - Durham Durham North Carolina United States 27705
59 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
60 Cape Fear Valley Health System Fayetteville North Carolina United States 28302-2000
61 Lenoir Memorial Hospital Cancer Center Kinston North Carolina United States 28503-1678
62 FirstHealth Moore Regional Hospital Pinehurst North Carolina United States 28374
63 New Hanover Regional Medical Center Wilmington North Carolina United States 28402-9025
64 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
65 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
66 Veterans Affairs Medical Center - Fargo Fargo North Dakota United States 58102
67 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
68 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
69 Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224
70 Lifespan: The Miriam Hospital Providence Rhode Island United States 02906
71 Veterans Affairs Medical Center - Dallas Dallas Texas United States 75216
72 Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas Dallas Texas United States 75235-9154
73 Green Mountain Oncology Group Bennington Vermont United States 05201
74 Vermont Cancer Center at University of Vermont Burlington Vermont United States 05401-3498
75 Veterans Affairs Medical Center - White River Junction White River Junction Vermont United States 05009
76 Martha Jefferson Hospital Charlottesville Virginia United States 22902
77 Virginia Oncology Associates - Norfolk Norfolk Virginia United States 23502
78 MBCCOP - Massey Cancer Center Richmond Virginia United States 23298-0037
79 Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke Virginia United States 24014
80 St. Mary's Medical Center Huntington West Virginia United States 25701
81 CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin United States 54301
82 Ministry Medical Group - Northern Region Rhinelander Wisconsin United States 54501
83 McGill University Montreal Quebec Canada H2W 1S6
84 University of Puerto Rico School of Medicine Medical Sciences Campus San Juan Puerto Rico 00936-5067

Sponsors and Collaborators

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

Investigators

  • Study Chair: Mark J. Ratain, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00048971
Other Study ID Numbers:
  • CALGB-60102
  • CALGB-60102
  • NCCTG-CALGB-60102
  • CDR0000257145
First Posted:
Jan 27, 2003
Last Update Posted:
Jul 6, 2016
Last Verified:
Jul 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
adenocarcinoma of the colon
stage III colon cancer
diarrhea
neutropenia
Additional relevant MeSH terms:
Neutropenia
Diarrhea

Study Results

No Results Posted as of Jul 6, 2016