NCT00034346

ABX-EGF in Combination With Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

A Two Part, Multiple Dose Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination With Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (planned)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in combination with paclitaxel and carboplatin in the treatment of advanced NSCLC.

Conditions

• Non-Small Cell Lung Cancer
• Neoplasm Metastasis
• Lung Cancer

Interventions

Type	Name	Description
DRUG	ABX-EGF
DRUG	paclitaxel
DRUG	carboplatin

Timeline

• Start date: 2002-01-01
• First posted: 2002-04-26
• Last updated: 2007-12-24