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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Sanofi-Aventis |
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00707473 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
Paranasal Sinuses Squamous Cell Carcinoma |
Drug: Docetaxel Drug: 5-Fluorouracil Drug: Cisplatin |
Phase II |
MedlinePlus related topics: | Cancer |
Drug Information available for: | Docetaxel Cisplatin Fluorouracil Salicylsalicylic acid Sodium salicylate |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 45 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Docetaxel, Cisplatin, and 5-Fluorouracil
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Drug: Docetaxel
75 mg/m^2 IV on day 1 of each cycle.
Drug: 5-Fluorouracil
750 mg/m^2 continuous infusion on days 1 through 4 of each cycle.
Drug: Cisplatin
75 mg/m^2 IV over 30-120 minutes on day 1 of each cycle.
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Show Detailed Description |
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ehab Y. Hanna, MD | 713-745-2672 |
United States, Texas | |||||
U.T. M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Principal Investigator: Ehab Y. Hanna, MD |
M.D. Anderson Cancer Center |
Sanofi-Aventis |
Principal Investigator: | Ehab Y. Hanna, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Ehab Y. Hanna, M.D. / Professor ) |
Study ID Numbers: | 2007-0433 |
First Received: | June 26, 2008 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00707473 |
Health Authority: | United States: Institutional Review Board |
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