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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00048971
First received: November 12, 2002
Last updated: July 14, 2015
Last verified: July 2015
  Purpose

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 Intervention
Colorectal Cancer
Diarrhea
Neutropenia
Genetic: mutation analysis
Genetic: polymorphic microsatellite marker analysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • response [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood specimens


Enrollment: 308
Study Start Date: April 2002
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with adenocarcinoma of the colon and previously enrolled on CALGB-89803.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048971

  Show 84 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Mark J. Ratain, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00048971     History of Changes
Other Study ID Numbers: CALGB-60102, CALGB-60102, NCCTG-CALGB-60102, CDR0000257145
Study First Received: November 12, 2002
Last Updated: July 14, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the colon
stage III colon cancer
diarrhea
neutropenia

Additional relevant MeSH terms:
Diarrhea
Neutropenia
Agranulocytosis
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on July 30, 2015