CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Gemcitabine 1000 mg/m² IV on days 1 and 8; docetaxel 30 mg/m² IV on days 1 and 8; cetuximab 100 mg/m² IV on cycle 1 day 1, then 250 mg/m² IV on days 8 and 15, with subsequent cycles at 250 mg/m² IV on days 1, 8, and 15AI-extracted
Key inclusion· 7
  • ✓Age ≥18 years
  • ✓Histologically confirmed non-small cell lung cancer
  • ✓Unresectable stage III or IV disease
  • ✓Measurable disease per imaging
Key exclusion· 3
  • ✕History of serious heart disease within 6 months before study entry
  • ✕Prior treatment with EGFR pathway-targeting agents
  • ✕Uncontrolled or significant concurrent disease

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

Search/NCT00193453
NCT00193453Phase 2Completed
CompareCT.gov

A Phase II Trial of First-Line Therapy With Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Stage III or IV Non-Small Cell Lung Cancer

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated Nov 13, 2012

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Docetaxel, and 1 other intervention for Lung Cancer. Completed, enrolled 69 participants across 10 sites.

Detailed Summary

This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartJul 1, 2005
Primary CompletionFeb 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.8 years ago

Interventions

Gemcitabinedrug

1000mg/m2 30min IV, Day 1 \& 8

Docetaxeldrug

30mg/m2, 30min IV, day 1 \& 8

Cetuximabdrug

100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 \& 15, all subsequent cycles 250mg/m2 IV day 1, 8, \& 15