Trials / Completed
CompletedNCT00401323
Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
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.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 568 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | docetaxel (XRP6976) | |
| DRUG | cisplatin | |
| DRUG | 5-fluorouracil (5-FU) |
Timeline
- Start date
- 1998-01-01
- Primary completion
- 2003-06-01
- Completion
- 2003-06-01
- First posted
- 2006-11-20
- Last updated
- 2011-01-20
Locations
20 sites across 20 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Guadeloupe, Hungary, Israel, Italy, Reunion, Russia, South Africa, Spain, Switzerland, Uruguay
Source: ClinicalTrials.gov record NCT00401323. Inclusion in this directory is not an endorsement.