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Sponsors and Collaborators: |
University of Alabama at Birmingham Bristol-Myers Squibb Pharmacia |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00581971 |
This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients with locally advanced or recurrent squamous cell carcinoma of the head and neck.
Condition | Intervention | Phase |
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Cancer |
Drug: celecoxib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment |
Official Title: | Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck |
Estimated Enrollment: | 40 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Tretment for this proptocol consists of radiotherapy, 70.2Gy, at 1.8Gy qd, Monday through Friday.Celecoxib 400mg bid is taken during radiotherapy, starting 1 week before radiotherapy. Carboplatin IV, AUC 2.0, weekly for weeks 1 through 7,Paclitaxel 45 mg/m2, weekly for weeks 1 through 7, and Celecoxib 400mg bid, continuing after therapy for two years or until disease progression.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient has:
Patients with hematocrit between 24 % and 30 % should undergo transfusion or treatment with epoetin, and may be enrolled.
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35249 |
Principal Investigator: | Sharon Spencer, M.D. | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( Sharon Spencer ) |
Study ID Numbers: | F020703003, Link No: 000276825 |
Study First Received: | December 20, 2007 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00581971 History of Changes |
Health Authority: | United States: Institutional Review Board |
Radiosensitization COX-2 inhibitor Celecoxib Head and Neck Cancer Chemoradiation |
Anti-Inflammatory Agents Celecoxib Analgesics, Non-Narcotic Head and Neck Neoplasms Cyclooxygenase Inhibitors |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Cyclooxygenase 2 Inhibitors |
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Cyclooxygenase 2 Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Head and Neck Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |