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Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
This study has been completed.
Study NCT00048971   Information provided by National Cancer Institute (NCI)
First Received: November 12, 2002   Last Updated: November 16, 2009   History of Changes

November 12, 2002
November 16, 2009
April 2002
 
 
 
Complete list of historical versions of study NCT00048971 on ClinicalTrials.gov Archive Site
 
 
 
Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
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.

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.

 
Observational
 
  • Colorectal Cancer
  • Diarrhea
  • Neutropenia
  • Genetic: mutation analysis
  • Genetic: polymorphic microsatellite marker analysis
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00048971
 
CDR0000257145, CALGB-60102, NCCTG-CALGB-60102
Cancer and Leukemia Group B
  • National Cancer Institute (NCI)
  • North Central Cancer Treatment Group
Study Chair: Mark J. Ratain, MD University of Chicago
Study Chair: Steven R. Alberts, MD Mayo Clinic
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP