Phase II Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Chemotherapy in Squamous Cell Carcinoma of the Oral Cavity With Molecular Endpoints
This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel,
cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity
to determine what effects these agents may have on cancer cells.
Approximately 60 patients will take part at multi-sites with potentially 20 patients
participating at the Emory Winship Cancer Institute in Atlanta, Georgia.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].
every 3 months
No
Nabil Saba, MD
Principal Investigator
Emory University Winship Cancer Institute
United States: Institutional Review Board
0414-2006
NCT00400205
August 2006
September 2009
Name | Location |
---|---|
Emory University Winship Cancer Institute | Atlanta, Georgia 30322 |