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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Department of Defense |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00527982 |
Primary Objectives:
To examine the effect of celecoxib treatment on histological response (defined in Appendix H), markers of proliferation (Ki-67), and apoptosis.
Secondary endpoints include time to second primary or recurrence and survival.
Condition | Intervention | Phase |
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Head and Neck Cancer Lung Cancer |
Drug: Celecoxib Other: No Treatment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Celecoxib as Adjuvant Biologic Therapy in Patients With Early Stage Head and Neck and Lung Cancer |
Estimated Enrollment: | 70 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Celecoxib treatment
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Drug: Celecoxib
600 mg PO daily for a total of 12 months.
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2: No Intervention
No treatment
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Other: No Treatment
No treatment given.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Waun K. Hong, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Waun K. Hong, MD/Professor ) |
Study ID Numbers: | 2004-0104 |
Study First Received: | September 10, 2007 |
Last Updated: | February 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00527982 History of Changes |
Health Authority: | United States: Institutional Review Board |
Head and Neck Cancer Lung Cancer Non-Small Cell Lung Cancer Celecoxib Celebrex |
Thoracic Neoplasms Anti-Inflammatory Agents Celecoxib Cyclooxygenase Inhibitors Adjuvants, Immunologic Respiratory Tract Diseases Analgesics, Non-Narcotic Lung Neoplasms |
Head and Neck Neoplasms Lung Diseases Non-small Cell Lung Cancer Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Carcinoma, Non-Small-Cell Lung |
Anti-Inflammatory Agents Thoracic Neoplasms Respiratory Tract Neoplasms Celecoxib Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Respiratory Tract Diseases |
Sensory System Agents Analgesics, Non-Narcotic Lung Neoplasms Therapeutic Uses Head and Neck Neoplasms Lung Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |