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| Sponsor: | Hoosier Oncology Group |
|---|---|
| Collaborators: |
Sanofi-Aventis Hoffmann-La Roche Walther Cancer Institute |
| Information provided by: | Hoosier Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00216138 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: Docetaxel Drug: Capecitabine Drug: Premedication |
Phase II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 19 |
| Study Start Date: | March 2004 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Docetaxel + Capecitabine
|
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
|
OUTLINE: This is a multi-center study.
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:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Delaware | |
| Helen F. Graham Cancer Center | |
| Newark, Delaware, United States, 19713 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Arnett Cancer Care | |
| Lafayette, Indiana, United States, 47904 | |
| Center for Cancer Care, Inc., P.C. | |
| New Albany, Indiana, United States, 47150 | |
| Northern Indiana Cancer Research Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Fort Wayne Oncology & Hematology, Inc | |
| Fort Wayne, Indiana, United States, 46815 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Medical Consultants, P.C. | |
| Muncie, Indiana, United States, 47303 | |
| Elkhart Clinic | |
| Elkhart, Indiana, United States, 46515 | |
| Oncology Hematology Associates of SW Indiana | |
| Evansville, Indiana, United States, 47714 | |
| Quality Cancer Center (MCGOP) | |
| Indianapolis, Indiana, United States, 46202 | |
| Center for Cancer Care at Goshen Health System | |
| Goshen, Indiana, United States, 46527 | |
| AP&S Clinic | |
| Terre Haute, Indiana, United States, 47804 | |
| Providence Medical Group | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Center for Hematology-Oncology of S Michigan | |
| Jackson, Michigan, United States, 49201 | |
| United States, Missouri | |
| Siteman Cancer Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Methodist Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| Study Chair: | David Potter, M.D. | Hoosier Oncology Group, LLC |
More Information
| Responsible Party: | Hoosier Oncology Group ( David Potter, M.D. ) |
| Study ID Numbers: | HOG HN02-40 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00216138 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Head and Neck Cancer |
|
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |