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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Department of Defense |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00527982 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
Celecoxib treatment
|
Drug: Celecoxib
600 mg PO daily for a total of 12 months.
|
|
2: No Intervention
No treatment
|
Other: No Treatment
No treatment given.
|
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: | Waun K. Hong, MD | U.T.M.D. Anderson Cancer Center |
More Information
| 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 |
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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 |