RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer.
OBJECTIVES: Primary * Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine. Secondary * Determine the clinical benefit, time to treatment failure (TTF), safety, and toxicity profile of this regimen in these patients. * Determine the pharmacokinetics (PK) and pharmacogenetics in these patients. * Correlate pharmacodynamic effects of this drug with toxicity and response in these patients. * Determine compliance and adherence to this regimen and correlate with PK parameters in these patients. OUTLINE: This is an open-label study. Patients receive a fixed-dose of oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
A total of 115 cycles of therapy were administered and five patients did not complete cycle 1. The median number of cycles initiated was four (range 1-16).
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Participants were followed to progression, evaluated every 12 weeks
Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks
The overall clinical benefit rate as assessed by number of participants with lack of progression for at least 24 weeks.
Time frame: 3-week cycles of treatment up to 16 cycles
Pharmacokinetics of Capecitabine and Metabolites as Assessed by Maximum Plasma Concentration
Pharmacokinetics of Capecitabine and metabolites \[5-fluoro-5'-deoxycytidine (5'-DFCR), 5-fluoro-5'-dexoxyuridine (5'-DFUR), and 5-fluorouracil (FU)\] assessed using maximum plasma concentration (Cmax) in ng/mL.
Time frame: 0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours
Pharmacokinetics of Capecitabine and Metabolites as Assessed by Area Under the Curve (AUC)
Pharmacokinetics of Capecitabine and metabolites \[5-fluoro-5'-deoxycytidine (5'-DFCR), 5-fluoro-5'-dexoxyuridine (5'-DFUR), and 5-FU\] assessed using AUC in ng\*h/mL.
Time frame: 0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours
Adherence and Compliance to Oral Medication Using Electronic Monitoring
This was assessed by number of participants who did not miss any doses of Capecitabine during treatment using the Medication Event Monitoring System (MEMS).
Time frame: 3-week cycles of treatment up to 16 cycles
Time to Treatment Failure
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Time to treatment failure in weeks
Time frame: 3-week cycles of treatment up to 16 cycles