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| Sponsored by: |
Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00401323 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| 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.
Contacts and Locations
Hide Study Locations| United States, New Jersey | |
| sanofi-aventis US | |
| Bridgewater, New Jersey, United States, 08807 | |
| Argentina | |
| Sanofi-Aventis | |
| Buenos Aires, Argentina | |
| Australia, New South Wales | |
| sanofi-aventis, Australia | |
| Macquarie Park, New South Wales, Australia | |
| Austria | |
| Sanofi-Aventis | |
| Vienna, Austria | |
| Belgium | |
| sanofi-aventis, Belgium | |
| Diegem, Belgium | |
| Brazil | |
| Sanofi-Aventis | |
| Rio de Janeiro, Brazil | |
| Canada, Quebec | |
| sanofi-aventis Canada | |
| Laval, Quebec, Canada | |
| France | |
| sanofi-aventis, France | |
| Paris, France | |
| Germany | |
| sanofi-aventis Germany | |
| Berlin, Germany | |
| Greece | |
| sanofi-aventis Greece | |
| Athens, Greece | |
| Guadeloupe | |
| Sanofi-Aventis | |
| Basse-Terre, Guadeloupe | |
| Hungary | |
| Sanofi-Aventis Hungaria | |
| Budapest, Hungary | |
| Israel | |
| sanofi-aventis Israel | |
| Natanya, Israel | |
| Italy | |
| sanofi-aventis Italy | |
| Milano, Italy | |
| Réunion | |
| Sanofi-Aventis | |
| Saint-Denis, Réunion | |
| Russian Federation | |
| Sanofi-Aventis | |
| Moscow, Russian Federation | |
| South Africa | |
| sanofi-aventis South Africa | |
| Midrand, South Africa | |
| Spain | |
| Sanofi-Aventis | |
| Madrid, Spain | |
| Switzerland | |
| sanofi-aventis Switzerland | |
| Geneva, Switzerland | |
| Uruguay | |
| Sanofi-Aventis | |
| Montevideo, Uruguay | |
More Information
| 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 |
