Investigation of Genetic Determinants of Capecitabine Toxicity

The University of Chicago

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Side-effect questionnaires; Other: research blood samples

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00977119

TBCRC 015 (Other Identifier)

09-056-B

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

240 participants in 1 patient group

Capecitabine

Description:

Women with breast cancer receiving capecitabine as treatment for their breast cancer.

Treatment:

Other: research blood samples

Other: Side-effect questionnaires