NCT00768131

A Study to Determine Whether EGFR Status by FISH Can Predict Results in Non Small Cell Lung Cancer (NSCLC) Patients Treated With Cetuximab, Carboplatin and Paclitaxel

A Randomized Phase II Trial to Assess the Predictive Value of Increased EGFR Copy Number by FISH in Patients With Advanced / Metastatic NSCLC Treated With Cetuximab and Carboplatin / Paclitaxel

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel

Conditions

• Lung Neoplasms
• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Cetuximab	Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision
DRUG	Paclitaxel	Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum
DRUG	Carboplatin	Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-10-07
• Last updated: 2015-10-28

Locations

14 sites across 1 country: United States