drugset / Trial / NCT00251498

Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

NCT00251498 ↗

Phase 2 Completed 82 enrolled Veeda Oncology Bristol-Myers Squibb · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to determine the efficacy (response rate) of cetuximab when administered in combination with docetaxel and carboplatin for treatment of patients with advanced non-small cell lung cancer. The secondary objectives of this study are: * to determine the time to progression and overall survival for patients with advanced NSCLC who are treated with the combination docetaxel, carboplatin , and cetuximab * to determine the toxicity of the combination in patients with advanced NSCLC. Patients with stages IIIB (pleural or pericardial effusion) and IV NSCLC who have not received any prior chemotherapy will be eligible to participate in the trial. Other eligibility criteria include: ECOG PS 0-1, normal hepatic and renal function, age \>18 years. Specific inclusion and exclusion criteria are detailed in Sections 4.2 and 4.3.

Timeline

Start
—
Primary completion
—
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous