Induction Therapy-Docetaxel, Cisplatin and Fluorouracil in Untreated Advanced Squamous Cell or Undifferentiated Carcinoma of the Paranasal Sinuses
The goal of this clinical research study is to learn if docetaxel, cisplatin, and 5-fluorouracil in combination, then followed by chemoradiotherapy is effective in controlling cancers of the paranasal sinuses.
Paranasal Sinus Neoplasms
Squamous Cell Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell or Undifferentiated Carcinoma of the Paranasal Sinuses|
- Number of Patients with Complete + Partial Response [ Time Frame: Response assessment after two 3 week cycles, then every 6 months for minimally 2 years ] [ Designated as safety issue: No ]Clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF).
|Study Start Date:||June 2008|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Docetaxel, Cisplatin, and 5-Fluorouracil
Docetaxel 75 mg/m^2 IV on day 1 of each cycle. Cisplatin 75 mg/m^2 IV over 30-120 minutes on day 1 of each cycle. 5-Fluorouracil 750 mg/m^2 continuous infusion on days 1 through 4 of each cycle.
75 mg/m^2 IV on day 1 of each cycle.
Other Name: TaxotereDrug: 5-Fluorouracil
750 mg/m^2 continuous infusion on days 1 through 4 of each cycle.
Other Names:Drug: Cisplatin
75 mg/m^2 IV over 30-120 minutes on day 1 of each cycle.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00707473
|Contact: Ehab Y. Hanna, MD||713-745-2672|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Ehab Y. Hanna, MD|
|Principal Investigator:||Ehab Y. Hanna, MD||M.D. Anderson Cancer Center|