Status:
WITHDRAWN
Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Myriad Genetic Laboratories, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (...
Detailed Description
Capecitabine, PK Testing, and DNA Analysis: Capecitabine is designed to interfere with the growth of cancer cells, which may cause the cells to die. It is cleared from the body by certain proteins (w...
Eligibility Criteria
Inclusion
- Patients must have a pathologic or cytologic diagnosis of invasive carcinoma of the breast.
- Patients must give informed consent for protocol participation.
- Age \>/= 18 years
- Patients must have and ECOG performance status of \</=2.
- Patients must be scheduled to receive capecitabine using a BID dosing strategy administered on days 1-14 of a 21-day cycle.
- Patients must agree to blood draws for PK/PD sampling.
- Patients are allowed to receive cytotoxic therapy in combination with capecitabine.
- Patients must not require concurrent radiation, or hormonal therapy while receiving protocol therapy
- Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics as prophylaxis is allowed.
- 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.
- 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 \</= 1.5 x ULN; AST and/or ALT \</= 2 x ULN; Alkaline phosphatase (liver component, if fractionated) \</= 2 x ULN; Serum creatinine within normal limits.
Exclusion
- Untreated or uncontrolled brain metastasis
- History of prior therapy with capecitabine
- Patient inability to take or absorb oral medications
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00960544
Start Date
January 1 2019
End Date
January 1 2021
Last Update
June 14 2019
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