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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Novartis |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00485485 |
Purpose
Primary Objective:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Squamous Cell Cancer |
Drug: Imatinib Mesylate Drug: Docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer |
| Estimated Enrollment: | 58 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Imatinib Mesylate + Docetaxel
|
Drug: Imatinib Mesylate
400 mg PO Daily
Drug: Docetaxel
60 mg/m^2 IV Over 1 Hour Every 3 Weeks
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Anne S. Tsao, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Anne S. Tsao, MD/Assistant Professor ) |
| Study ID Numbers: | 2006-0362 |
| Study First Received: | June 12, 2007 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00485485 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Head and Neck Cancer Squamous Cell Cancer Imatinib Mesylate Gleevec |
Imatinib STI571 Docetaxel Taxotere |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Docetaxel |
Imatinib Neoplasms Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |