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

Sponsor:	Cancer and Leukemia Group B
Collaborators:	National Cancer Institute (NCI) North Central Cancer Treatment Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00048971

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
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:

MedlinePlus related topics: Cancer Colorectal Cancer Diarrhea

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2002

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.

PROJECTED ACCRUAL: Approximately 308 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

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

Show 84 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

North Central Cancer Treatment Group

Investigators

Study Chair:	Mark J. Ratain, MD	University of Chicago
Study Chair:	Steven R. Alberts, MD	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000257145, CALGB-60102, NCCTG-CALGB-60102
Study First Received:	November 12, 2002
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00048971 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the colon
stage III colon cancer
diarrhea
neutropenia

Additional relevant MeSH terms:

Diarrhea
Digestive System Neoplasms
Signs and Symptoms, Digestive
Hematologic Diseases
Gastrointestinal Diseases
Colonic Diseases
Agranulocytosis
Leukocyte Disorders
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Signs and Symptoms
Neutropenia
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Leukopenia
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009