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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00401323 |
The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
Condition | Intervention | Phase |
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Head and Neck Neoplasms Neoplasm Recurrence, Local Neoplasm Metastasis |
Drug: docetaxel (XRP6976) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck. |
Estimated Enrollment: | 642 |
Study Start Date: | January 1998 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.
Study ID Numbers: | EFC6051, XRP6976G-322 |
Study First Received: | November 17, 2006 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00401323 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Carcinoma, Squamous Cell of Head and Neck Squamous Cell Carcinoma Recurrence Carcinoma Docetaxel Cisplatin Head and Neck Neoplasms |
Fluorouracil Epidermoid Carcinoma Neoplasm Metastasis Neoplasm Recurrence, Local Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Disease Attributes Neoplasms by Histologic Type Antineoplastic Agents Pharmacologic Actions Recurrence Carcinoma Docetaxel Neoplasms Neoplastic Processes |
Neoplasms by Site Pathologic Processes Therapeutic Uses Head and Neck Neoplasms Neoplasm Metastasis Neoplasm Recurrence, Local Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |