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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00707473 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Paranasal Sinuses Squamous Cell Carcinoma |
Drug: Docetaxel Drug: 5-Fluorouracil Drug: Cisplatin |
Phase 2 |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Docetaxel, Cisplatin, and 5-Fluorouracil |
Drug: Docetaxel
75 mg/m^2 IV on day 1 of each cycle.
Other Name: Taxotere
Drug: 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.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00707473 History of Changes |
| Other Study ID Numbers: | 2007-0433 |
| Study First Received: | June 26, 2008 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Carcinoma of Paranasal Sinuses Paranasal Sinuses Nasal Sinuses Nasal Cavity Squamous Cell Carcinoma Undifferentiated Carcinoma |
Poorly Differentiated Carcinoma Docetaxel 5-Fluorouracil Cisplatin Platinol® Platinol®-AQ |
|
Carcinoma Carcinoma, Squamous Cell Paranasal Sinus Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Nose Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nose Diseases Respiratory Tract Diseases Paranasal Sinus Diseases Respiratory Tract Neoplasms |
Otorhinolaryngologic Diseases Docetaxel Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |