Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck
Summary
Recent progress in treatment of recurrent/metastatic SCCHN has been made with the introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and 17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU. Previous studies have shown that the capecitabine/docetaxel combination has a synergistic inhibition of tumor growth, resulting in significantly superior efficacy in time to disease progression (TTP), overall survival, median survival and objective tumor response rate compared to docetaxel alone. This trial will investigate the efficacy the combination of docetaxel and capecitabine in treating patients with recurrent/metastatic SCCHN.
Timeline
- Start
- 2004-03
- Primary completion
- 2007-09
- Completion
- 2007-09
Outcome
Outcome not reported
Stopped: “Interim analysis results did not meet criteria for second stage of trial”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Comparator | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Comparator | Dexamethasone | Small molecule | — | — |