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

NCT00499655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2017-03-29

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Karen Reckamp · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00499655 on ClinicalTrials.gov