Clinical trial NCT00977119: Investigation of Genetic Determinants of Capecitabine Toxicity
Official title: Investigation of Genetic Determinants of Capecitabine Toxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
capecitabine
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Translational Breast Cancer Research Consortium
name: National Institutes of Health (NIH)
First posted: 2009-09-15
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving treatment with capecitabine for breast cancer at a participating academic medical center.

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.


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

Primary outcomes:
measure: Genetic variants of toxicity
timeFrame: 2 years
Secondary outcomes:
measure: Time to toxicity based on genetics
timeFrame: 2 years
measure: Multiple genetic variants as predictors
timeFrame: 2 years
measure: Genome-wide association (potential)
timeFrame: 2 years
measure: Correlative sample collection
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor University
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of Chicago
name: Peter H O'Donnell, MD
role: STUDY_CHAIR
References: