CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
erlotinib hydrochloride +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00499655
NCT00499655Phase 2Completed
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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

City of Hope Medical Center·interventional·Posted Jul 11, 2007·Updated Mar 29, 2017

In Brief

A Phase 2 clinical trial evaluating erlotinib hydrochloride, celecoxib, and 7 other interventions for Recurrent Non-small Cell Lung Cancer and 2 related conditions. Completed, enrolled 107 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
CountriesUnited States
CollaboratorsOSI Pharmaceuticals

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2007
Enrollment StartNov 1, 2007
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 19.0 years ago

Interventions

erlotinib hydrochloridedrug

Given orally

celecoxibdrug

Given orally

placeboother

Given orally

laboratory biomarker analysisother

Correlative studies

immunohistochemistry staining methodother

Correlative studies

fluorescence in situ hybridizationgenetic

Correlative studies

mutation analysisgenetic

Correlative studies

protein expression analysisgenetic

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gene expression analysisgenetic

Correlative studies