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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
19
Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle
Capecitabine 825 mg/m2 po bid, days 1-14
Dexamethasone and antiemetic premedication
Helen F. Graham Cancer Center
Newark, Delaware, United States
University of Chicago
Chicago, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States
Arnett Cancer Care
Lafayette, Indiana, United States
Medical Consultants, P.C.
Muncie, Indiana, United States
...and 8 more locations
- To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine
Time frame: 24 months
To assess toxicity of the combination
Time frame: 24 months
To determine whether the status of calpain, calpain activation,(EGFR) expression, Cox-2 expression, TS, TP, DPD, and/or CYP3A4/CYP3A5 will predict treatment
Time frame: 24 months
Efficacy and safety analyses on special sub-cohorts
Time frame: 24 months
To determine the progression free survival and overall survival
Time frame: 24 months
To assess change in analgesic usage with this protocol therapy
Time frame: 24 months
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