Status:
UNKNOWN
Association of Capecitabine Pharmacokinetics and Toxicity With Aging
Lead Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborating Sponsors:
University of Newcastle Upon-Tyne
Conditions:
Breast Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a multi-centre prospective non-interventional study designed to evaluate the effects of patient age on the pharmacokinetics of capecitabine and its metabolites 5'DFCR, 5'DFUR, and 5-FU. In add...
Eligibility Criteria
Inclusion
- 1\) Histologic or cytologic diagnosis of breast cancer or colorectal cancer. Patients should have disease that is suitable for capecitabine monotherapy as defined by the NICE Guidelines.
- 2\) Patients must be within the first week of their first cycle of capecitabine treatment.
- 3\) Estimated life expectancy of greater than 3 months. 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5) Total serum bilirubin less than or equal to 25 micromol/L. 6) Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than 2.5 times the upper limit of the normal range.
- 7\) Serum albumin level greater than 32 g/L. 8) Creatinine clearance greater than or equal to 30 mL/minute. 9) Blood haemoglobin level of greater than 9 g/dL, with transfusion allowed. 10) Absolute neutrophil count greater than 2.5 x 109/L. 11) Platelet count greater than 100 x 109/L. 12) 18 years of age or older. 13) Written informed consent.
Exclusion
- Pregnancy or breast feeding.
- Known HIV, Hepatitis B, or Hepatitis C infection.
- Known Gilbert syndrome.
- Uncontrolled diabetes (HbA1c greater than 7.5%).
- Any condition or disease that might affect oral absorption of medications, including:
- Crohn's disease
- Ulcerative colitis
- Major gastric or small bowel resection
- \-
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03465202
Start Date
May 1 2016
End Date
November 1 2019
Last Update
March 14 2018
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