Investigation of Genetic Determinants of Capecitabine Toxicity

Breast Cancer Clinical Trial

Official title:

Investigation of Genetic Determinants of Capecitabine Toxicity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00977119
• Other study ID #: 09-056-B
• Secondary ID: TBCRC 015
• Status: Active, not recruiting
• Start date: November 2009
• Est. completion date: May 15, 2024

Study information

• Verified date: April 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Side-effect questionnaires
Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly
• research blood samples
Blood samples for research on DNA before starting treatment and after 4 cycles of treatment

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins	Baltimore	Maryland
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Baylor University	Houston	Texas
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota
United States	Georgetown University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	National Institutes of Health (NIH), Translational Breast Cancer Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic variants of toxicity		2 years
Secondary	Time to toxicity based on genetics		2 years
Secondary	Multiple genetic variants as predictors		2 years
Secondary	Genome-wide association (potential)		2 years
Secondary	Correlative sample collection		2 years