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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital Sanofi-Aventis |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00139230 |
The purpose of this study is to further test a combination chemotherapy regimen for the treatment of squamous cell carcinoma of the head and neck and to see if the addition of supportive medicine can help reduce the side effects of these drugs.
Condition | Intervention | Phase |
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Squamous Cell Carcinoma Carcinoma of Head/Neck |
Drug: Taxotere Drug: Cisplatin Drug: 5-Fluorouracil Drug: Leucovorin Drug: G-CSF Drug: Ciprofloxacin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | TPLF-4, Compressed TPLF for Locally Advanced Squamous Cell Carcinoma |
Estimated Enrollment: | 30 |
Study Start Date: | January 1997 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Marshall Posner, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | 96-184 |
Study First Received: | August 29, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00139230 |
Health Authority: | United States: Institutional Review Board |
Squamous Cell Carcinoma of Head and Neck Compressed TPFL Taxotere Growth Factor Support |
Squamous cell carcinoma Leucovorin Carcinoma Epidermoid carcinoma Docetaxel Ciprofloxacin Cisplatin |
Fluorouracil Carcinoma, squamous cell Neoplasms, Squamous Cell Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Vitamin B Complex Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Vitamins Therapeutic Uses Micronutrients Nucleic Acid Synthesis Inhibitors |