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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT00499655
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 11, 2007
Start date
Nov 30, 2007
Status verified
Feb 2017
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
107 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I
    Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
  • Experimental: Arm II
    Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Until disease progression, up to 5 years. ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
South Pasadena Cancer CenterSouth PasadenaCalifornia91030-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CASouth Pasadena Cancer Center· South Pasadena, CA

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