Investigation of Genetic Determinants of Capecitabine Toxicity

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Translational Breast Cancer Research Consortium
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00977119
First received: September 14, 2009
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia).

Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.


Condition Intervention
Breast Cancer
Other: Side-effect questionnaires
Other: research blood samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Genetic Determinants of Capecitabine Toxicity

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Genetic variants of toxicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to toxicity based on genetics [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Multiple genetic variants as predictors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Genome-wide association (potential) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlative sample collection [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood (including DNA)


Enrollment: 240
Study Start Date: November 2009
Estimated Study Completion Date: May 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Capecitabine
Women with breast cancer receiving capecitabine as treatment for their breast cancer.
Other: Side-effect questionnaires
Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly
Other: research blood samples
Blood samples for research on DNA before starting treatment and after 4 cycles of treatment

  Eligibility

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

Patients receiving treatment with capecitabine for breast cancer at a participating academic medical center.

Criteria

Inclusion Criteria:

  • women with breast cancer in whom single agent capecitabine therapy is being considered
  • aged 18 years and older

Exclusion Criteria:

  • patients who have previously received capecitabine are excluded
  • patients cannot be receiving capecitabine in combination with another cancer chemotherapy; concurrent use of trastuzumab is not permitted; concurrent use of zoledronic acid is allowed
  • serum albumin less than 3.0 g/dL within the last 30 days
  • creatinine clearance (CrCL) or glomerular filtration rate (GFR) less than 60 mL/min [/body surface area (BSA)] (within the last 30 days)
  • inability to understand and give informed consent to participate
  • patients with a history of inflammatory bowel disease requiring therapy or patients with chronic diarrhea syndromes or paralytic ileus
  • patients with prior or concurrent pelvic irradiation
  • patients who use an ostomy for fecal excretion
  • there is no limit on the number of prior chemotherapies; the decision to use capecitabine is determined solely by the treating physician
  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: NCT00977119

Locations
United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27708
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 73232
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Baylor University
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Chicago
Translational Breast Cancer Research Consortium
Investigators
Study Chair: Peter H O'Donnell, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00977119     History of Changes
Other Study ID Numbers: 09-056-B, TBCRC 015
Study First Received: September 14, 2009
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
breast cancer
capecitabine

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014