NCT00499655

Erlotinib Hydrochloride With or Without Celecoxib in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given orally
DRUG	celecoxib	Given orally
OTHER	placebo	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	immunohistochemistry staining method	Correlative studies
GENETIC	fluorescence in situ hybridization	Correlative studies
GENETIC	mutation analysis	Correlative studies
GENETIC	protein expression analysis	Correlative studies
GENETIC	gene expression analysis	Correlative studies

Timeline

• Start date: 2007-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2007-07-11
• Last updated: 2017-03-29
• Results posted: 2017-03-01

Locations

2 sites across 1 country: United States