CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
erlotinib hydrochloride +2 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/NCT00660816
NCT00660816Phase 2Completed

Randomized Phase II Trial, Comparing Standard of Care Chemotherapy (Pemetrexed or Docetaxel) Plus Erlotinib to Standard of Care Chemotherapy (Pemetrexed or Docetaxel) Alone in EGFR TKI-Responsive Non-Small Cell Lung Cancer

Case Comprehensive Cancer Center·interventional·Posted Apr 17, 2008·Updated Oct 12, 2015

In Brief

A Phase 2 clinical trial evaluating erlotinib hydrochloride, pemetrexed disodium, and 1 other intervention for Lung Cancer. Completed, enrolled 46 participants across 13 sites.

Detailed Summary

RATIONALE: Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving pemetrexed disodium or docetaxel together with erlotinib hydrochloride is more effective than giving pemetrexed disodium or docetaxel alone in treating non-small lung cancer. PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium or docetaxel together with or without erlotinib hydrochloride works in treating 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
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartJan 1, 2008
Primary CompletionApr 1, 2013
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 18.2 years ago

Interventions

erlotinib hydrochloridedrug

Given orally once daily on days 2-19.

pemetrexed disodiumdrug

Given IV over 10 minutes on day 1

docetaxeldrug

IV over 60 minutes on day 1.