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Trial record 51 of 127 for:    colon cancer | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00048971
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date November 12, 2002
First Posted Date January 27, 2003
Last Update Posted Date July 6, 2016
Study Start Date April 2002
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2015)
response [ Time Frame: Up to 4 years ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00048971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood specimens
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with adenocarcinoma of the colon and previously enrolled on CALGB-89803.
Condition
  • Colorectal Cancer
  • Diarrhea
  • Neutropenia
Intervention
  • Genetic: mutation analysis
  • Genetic: polymorphic microsatellite marker analysis
Study Groups/Cohorts 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.
Interventions:
  • Genetic: mutation analysis
  • Genetic: polymorphic microsatellite marker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 14, 2015)
308
Original Enrollment Not Provided
Actual Study Completion Date November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00048971
Other Study ID Numbers CALGB-60102
CALGB-60102
NCCTG-CALGB-60102
CDR0000257145 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Mark J. Ratain, MD University of Chicago
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2016