drugset / Trial / NCT00908336

Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen

NCT00908336 ↗

Phase 2 Unknown 70 enrolled Hospital Arnau de Vilanova
RandomizedParallel-groupOpen-labelTreatment

Summary

Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population. However, several preclinical and phase I studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy. This study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.

Timeline

Start
2009-03
Primary completion
2010-08
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Erlotinib Small molecule 150 mg Oral