CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 147 enrolled
Drug / intervention
erlotinib hydrochloride +1 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/NCT00283244
NCT00283244Phase 2Completed

Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Jan 27, 2006·Updated Apr 24, 2017

In Brief

A Phase 2 clinical trial evaluating erlotinib hydrochloride and gemcitabine hydrochloride for Lung Cancer. Completed, enrolled 147 participants across 11 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether gemcitabine and erlotinib are more effective when given alone or together in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2006
Enrollment StartMar 1, 2006
Primary CompletionSep 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 20.4 years ago

Interventions

erlotinib hydrochloridedrug

given orally

gemcitabine hydrochloridedrug

given IV