Spots Global Cancer Trial Database for Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck
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Trial Identification
Brief Title: Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck
Official Title: 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
Study ID: NCT00216138
Conditions
Study Description
Brief 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Center for Cancer Care, Inc., P.C., New Albany, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Providence Medical Group, Terre Haute, Indiana, United States
AP&S Clinic, Terre Haute, Indiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Center for Hematology-Oncology of S Michigan, Jackson, Michigan, United States
Siteman Cancer Center, St. Louis, Missouri, United States
Methodist Cancer Center, Omaha, Nebraska, United States
Contact Details
Name: David Potter, M.D.
Affiliation: Hoosier Oncology Group, LLC
Role: STUDY_CHAIR
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