Capecitabine in Treating Patients With Metastatic Breast Cancer

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Capecitabine	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).

Primary Outcome Measures

Name	Time	Method
Response Rate	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 Outcome Measures

Name	Time	Method
Adherence and Compliance to Oral Medication Using Electronic Monitoring	3-week cycles of treatment up to 16 cycles	This was assessed by number of participants who did not miss any doses of Capecitabine during treatment using the Medication Event Monitoring System (MEMS).
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 \[5-fluoro-5'-deoxycytidine (5'-DFCR), 5-fluoro-5'-dexoxyuridine (5'-DFUR), and 5-fluorouracil (FU)\] assessed using maximum plasma concentration (Cmax) in ng/mL.
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	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 to Treatment Failure	3-week cycles of treatment up to 16 cycles	Time to treatment failure in weeks
Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks	3-week cycles of treatment up to 16 cycles	The overall clinical benefit rate as assessed by number of participants with lack of progression for at least 24 weeks.

Locations (3): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
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Annapolis, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, United States