Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- capecitabine
- Conditions
- Breast Cancer
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 26
- Locations
- 3
- Primary Endpoint
- Response Rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Capecitabine
26 patients received the pre-defined starting dose of capecitabine of 3,000 mg orally daily given in two divided doses. Two thirds of the patients received either the same dose or a 500 mg lower dose compared to what would have been administered with a commonly used body surface area (BSA)-dosing schedule (2,000 mg/m2 with rounding down to nearest 500 mg multiple).
Intervention: capecitabine
Outcomes
Primary Outcomes
Response Rate
Time Frame: Participants were followed to progression, evaluated every 12 weeks
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.
Secondary Outcomes
- Adherence and Compliance to Oral Medication Using Electronic Monitoring(3-week cycles of treatment up to 16 cycles)
- Pharmacokinetics of Capecitabine and Metabolites as Assessed by Maximum Plasma Concentration(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)(0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours)
- Time to Treatment Failure(3-week cycles of treatment up to 16 cycles)
- Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks(3-week cycles of treatment up to 16 cycles)