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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Bristol-Myers Squibb |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00402545 |
The purpose of this research study is to determine the safest and most effective dose of 5-FU that can be given with docetaxel (Taxotere), Cisplatin and cetuximab to patients with newly diagnosed locally advanced squamous cell carcinoma of the head and neck. We will also be studying the toxicity of this regimen of 4 drugs and the tumor response.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Neoplasms |
Drug: Cetuximab Drug: Docetaxel Drug: Cisplatin Drug: 5-Fluorouracil |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of Cetuximab/Docetaxel(Taxotere)/Cisplatin/5-Fluorouracil (C-TPF) in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck |
Estimated Enrollment: | 29 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
During treatment a needle will be inserted into the port-a-cath through which the chemotherapy will be given. If the participant chooses not to have a port-a-cath, they will need to be hospitalized at Brigham and Women's Hospital to receive chemotherapy (approximately 5 days).
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 |
Principal Investigator: | Robert I Haddad, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Robert Haddad, MD ) |
Study ID Numbers: | 06-128, CA225249 |
Study First Received: | November 21, 2006 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00402545 History of Changes |
Health Authority: | United States: Institutional Review Board |
SCCHN C-TPF 5-FU squamous cell carcinoma of the head and neck |
Antimetabolites Immunologic Factors Cetuximab Carcinoma, Squamous Cell of Head and Neck Squamous Cell Carcinoma Immunosuppressive Agents Carcinoma Docetaxel |
Cisplatin Radiation-Sensitizing Agents Head and Neck Neoplasms Fluorouracil Epidermoid Carcinoma Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cetuximab Immunosuppressive Agents Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Head and Neck Neoplasms Fluorouracil Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |