Overview

Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism

Status:
Withdrawn
Trial end date:
2021-01-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to find out how gene expression (as well as how often this expression occurs) in patients with breast cancer affects how Xeloda® (capecitabine) is cleared (passed through the urine) from the body. The safety of capecitabine will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Myriad Genetic Laboratories, Inc.
Treatments:
Capecitabine
Criteria
Inclusion Criteria:

1. Patients must have a pathologic or cytologic diagnosis of invasive carcinoma of the
breast.

2. Patients must give informed consent for protocol participation.

3. Age >/= 18 years

4. Patients must have and ECOG performance status of
5. Patients must be scheduled to receive capecitabine using a BID dosing strategy
administered on days 1-14 of a 21-day cycle.

6. Patients must agree to blood draws for PK/PD sampling.

7. Patients are allowed to receive cytotoxic therapy in combination with capecitabine.

8. Patients must not require concurrent radiation, or hormonal therapy while receiving
protocol therapy

9. Patients must not have an active infection requiring the use of intravenous
antibiotics. The use of oral antibiotics as prophylaxis is allowed.

10. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of
the importance of avoiding pregnancy during trial participation and the potential risk
factors for an unintentional pregnancy. In addition, men enrolled on this study should
understand the risks to any sexual partner of childbearing potential. Both men and
women should practice an effective method of birth control while receiving
capecitabine.

11. Patients must have recovered to grade <1 from all acute toxicity of previous
chemotherapy, radiation or hormonal therapy and have adequate hematologic and hepatic
function: Granulocyte count >/= 1,500/mcL; Platelet count >/= 100,000/mcL; Bilirubin
fractionated)
Exclusion Criteria:

1. Untreated or uncontrolled brain metastasis

2. History of prior therapy with capecitabine

3. Patient inability to take or absorb oral medications