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Investigation of Genetic Determinants of Capecitabine Toxicity

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: NCT00977119
Recruitment Status : Active, not recruiting
First Posted : September 15, 2009
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
Translational Breast Cancer Research Consortium
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date September 14, 2009
First Posted Date September 15, 2009
Last Update Posted Date April 22, 2019
Study Start Date November 2009
Actual Primary Completion Date May 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 14, 2009)
Genetic variants of toxicity [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00977119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 14, 2009)
  • Time to toxicity based on genetics [ Time Frame: 2 years ]
  • Multiple genetic variants as predictors [ Time Frame: 2 years ]
  • Genome-wide association (potential) [ Time Frame: 2 years ]
  • Correlative sample collection [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation of Genetic Determinants of Capecitabine Toxicity
Official Title Investigation of Genetic Determinants of Capecitabine Toxicity
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood (including DNA)
Sampling Method Non-Probability Sample
Study Population Patients receiving treatment with capecitabine for breast cancer at a participating academic medical center.
Condition Breast Cancer
Intervention
  • 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
Study Groups/Cohorts Capecitabine
Women with breast cancer receiving capecitabine as treatment for their breast cancer.
Interventions:
  • Other: Side-effect questionnaires
  • Other: research blood samples
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 Active, not recruiting
Actual Enrollment
 (submitted: February 18, 2014)
240
Original Estimated Enrollment
 (submitted: September 14, 2009)
250
Estimated Study Completion Date June 2020
Actual Primary Completion Date May 31, 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00977119
Other Study ID Numbers 09-056-B
TBCRC 015 ( Other Identifier: Translational Breast Cancer Reseach Consortium )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Chicago
Study Sponsor University of Chicago
Collaborators
  • Translational Breast Cancer Research Consortium
  • National Institutes of Health (NIH)
Investigators
Study Chair: Peter H O'Donnell, MD University of Chicago
PRS Account University of Chicago
Verification Date April 2019