NCT00216138

Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck

A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: This is a multi-center study. * Dexamethasone and antiemetic premedication1. * Docetaxel: 60 mg/m2 for a 60 minute infusion day 1 of each cycle * Capecitabine: 825 mg/m2 po BID Days 1-14 Repeat every 21 days until tumor progression or toxicity that requires discontinuation of therapy Performance status: ECOG performance status 0 or 1 Life expectancy: At least 3 months Hematopoietic: * ANC of \> 1,500/mm3 * Platelets \> 100,000/mm3 * Hemoglobin \> 8 gm/dl Hepatic: * Total Bilirubin £ ULN * Albumin \> 3 * Maximum Alk Phos \> 2.5 x \< 5 x ULN Renal: * Creatinine clearance of \> 50 ml/ min (by Cockcroft-Gault) Cardiovascular: * No decompensated congestive heart failure or active angina. * Clinically significant cardiac disease not well controlled with medication (eg. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction in the past 12 months is not allowed. Pulmonary: * Not specified

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle
DRUG	Capecitabine	Capecitabine 825 mg/m2 po bid, days 1-14
DRUG	Premedication	Dexamethasone and antiemetic premedication

Timeline

• Start date: 2004-03-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2005-09-22
• Last updated: 2011-05-02

Locations

18 sites across 1 country: United States