Capecitabine in Treating Patients With Metastatic Breast Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer|
- Response Rate [ Time Frame: Participants were followed to progression, evaluated every 12 weeks ] [ Designated as safety issue: No ]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.
- Clinical Benefit, Time to Treatment Failure, Safety and Toxicity [ Time Frame: Time to progression ] [ Designated as safety issue: Yes ]
- Pharmacokinetic and Pharmacodynamic Effects [ Time Frame: Time to progression ] [ Designated as safety issue: No ]
- Adherence and Compliance to Oral Medication Using Electronic Monitoring [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Study Completion Date:||November 2012|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine.
- 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.
|United States, Maryland|
|DeCesaris Cancer Institute at Anne Arundel Medical Center|
|Annapolis, Maryland, United States, 21401|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Antonio C. Wolff, MD||Sidney Kimmel Comprehensive Cancer Center|