drugset / Trial / NCT00225056

Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma

NCT00225056 ↗

Phase 2 Terminated 43 enrolled Oncology Specialties, Alabama
Non-randomizedSingle-groupOpen-labelTreatment

Summary

In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.

Timeline

Start
2003-10
Primary completion
—
Completion
2006-11

Outcome

Outcome not reported

Stopped (Enrollment): “Terminated due to lack of accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 800 mg/m2 Oral
Subject Docetaxel Small molecule 30 mg/m2 —

Indications