Breast Cancer Clinical Trial
Official title:
Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan
NCT number | NCT00960544 |
Other study ID # | 2007-0003 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2019 |
Est. completion date | January 2021 |
Verified date | June 2019 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2021 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 </=2. 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 </= 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 Criteria: 1. Untreated or uncontrolled brain metastasis 2. History of prior therapy with capecitabine 3. Patient inability to take or absorb oral medications |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Myriad Genetic Laboratories, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling) | Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling) | PK testing blood draw before first dose of capecitabine, and at 30, 60, and 90 minutes, then 2, 6, 8, and 10 hours after first dose. |
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