NCT00193453

Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Upon determination of eligibility all patients will receive: * Docetaxel + Gemcitabine + Cetuximab

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	1000mg/m2 30min IV, Day 1 \& 8
DRUG	Docetaxel	30mg/m2, 30min IV, day 1 \& 8
DRUG	Cetuximab	100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 \& 15, all subsequent cycles 250mg/m2 IV day 1, 8, \& 15

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-02-01
• Completion: 2009-12-01
• First posted: 2005-09-19
• Last updated: 2012-11-13
• Results posted: 2012-11-13

Locations

10 sites across 1 country: United States