Investigation of Genetic Determinants of Capecitabine Toxicity

Completed

• Conditions: Breast Cancer
• Interventions: Other: Side-effect questionnaires; Other: research blood samples

• Registration Number: NCT00977119
• Lead Sponsor: University of Chicago

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 available

Study Timeline

• Study First Submitted: 2009-09-14
• Study First Submitted QC: 2009-09-14
• Study First Posted: 2009-09-15
• Study Start: 2009-11-23
• Primary Completion: 2021-06-21
• Study Completion: 2021-06-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Capecitabine	research blood samples	Women with breast cancer receiving capecitabine as treatment for their breast cancer.
Capecitabine	Side-effect questionnaires	Women with breast cancer receiving capecitabine as treatment for their breast cancer.

Primary Outcome Measures

Name	Time	Method
Genetic variants of toxicity	2 years

Secondary Outcome Measures

Name	Time	Method
Multiple genetic variants as predictors	2 years
Genome-wide association (potential)	2 years
Time to toxicity based on genetics	2 years
Correlative sample collection	2 years

Trial Locations

Locations (13)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States

M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Baylor University; 🇺🇸 Houston, Texas, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States