Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00062101
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 (PO)
  • celecoxib — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor. Combining erlotinib with celecoxib may kill more tumor cells. .

Key Dates

First listed
Jun 6, 2003
Start date
Jan 31, 2004
Status verified
Jun 2013
Primary completion
Jan 31, 2006

Study Design

Enrollment
80 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (erlotinib hydrochloride, celecoxib)
    Patients receive oral erlotinib once daily and oral celecoxib twice daily.
  • Experimental: Group II (erlotinib hydrochloride)
    Patients receive erlotinib as in group 1.

Primary Outcome Measure

Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From the start of treatment until disease progression/recurrence, assessed up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-

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