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| Sponsor: | City of Hope Medical Center |
|---|---|
| Collaborator: |
OSI Pharmaceuticals |
| Information provided by (Responsible Party): | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00499655 |
Purpose
RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with celecoxib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride together with celecoxib works compared with erlotinib hydrochloride alone in treating patients with stage IIIB-IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer |
Drug: erlotinib hydrochloride Drug: celecoxib Other: placebo Other: laboratory biomarker analysis Other: immunohistochemistry staining method Genetic: fluorescence in situ hybridization Genetic: mutation analysis Genetic: protein expression analysis Genetic: gene expression analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Placebo-Controlled Phase II Clinical Trial of Combination Erlotinib (Tarceva) and Celecoxib (Celebrex) Versus Erlotinib (Tarceva)/Placebo in Advanced Non-Small Cell Lung Cancer Patients |
| Estimated Enrollment: | 106 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
|
Drug: erlotinib hydrochloride
Given orally
Other Names:
Other: placebo
Given orally
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Genetic: fluorescence in situ hybridization
Correlative studies
Other Name: fluorescence in situ hybridization (FISH)
Genetic: mutation analysis
Correlative studies
Genetic: protein expression analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
|
|
Experimental: Arm II
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
|
Drug: erlotinib hydrochloride
Given orally
Other Names:
Drug: celecoxib
Given orally
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Genetic: fluorescence in situ hybridization
Correlative studies
Other Name: fluorescence in situ hybridization (FISH)
Genetic: mutation analysis
Correlative studies
Genetic: protein expression analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
|
PRIMARY OBJECTIVES:
I. Comparison of progression-free survival (PFS) in patients receiving erlotinib + celecoxib vs. erlotinib + placebo for advanced NSCLC.
SECONDARY OBJECTIVES:
I. Objective tumor response rate as defined by RECIST Criteria for subjects receiving erlotinib/celecoxib treatment arms.
II. Categorize the change in e-cadherin expression from baseline to week 8 in a subset of subjects.
III. Evaluation of overall survival (OS). IV. Measurement of COX-2, EGFR by immunohistochemistry and EGFR amplification by FISH, and EGFR mutation status to correlate with clinical response.
V. Measurement of change in urinary PGE-M and correlation with response.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
ARM II: Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
In both arms, treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion
Exclusion
Contacts and Locations| United States, California | |
| City of Hope | |
| Duarte, California, United States, 91010 | |
| City of Hope Medical Group Inc | |
| Pasadena, California, United States, 91105 | |
| Principal Investigator: | Karen Reckamp | Beckman Research Institute |
More Information
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00499655 History of Changes |
| Other Study ID Numbers: | 06254, NCI-2010-00353, CDR0000549751 |
| Study First Received: | July 10, 2007 |
| Last Updated: | September 9, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Celecoxib Erlotinib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents Protein Kinase Inhibitors |