drugset / Trial / NCT00678964

Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT00678964

Phase 2 Unknown 260 enrolled LungenClinic Grosshansdorf
RandomizedParallel-groupOpen-labelTreatment

Summary

60% of all malignant diseases occur in patients who are 65 years or older. For these patients, aggressive treatments are often not suitable due to reduced life-expectancy, reduced general condition, comorbidities, and reduced vital functions which can lead to increased adverse effects of chemotherapy. Therefore, it is important to investigate alternative therapy options for elderly patients. Erlotinib is an orally applied medication which is associated with reasonable toxicity. This targeted agent may prove an effective and well-tolerated first-line therapy in elderly patients with advanced non small cell lung cancer. Therefore, the aim of this study is to investigate the progression-free survival of the combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will be no significant reduction of efficiency this may provide elderly patients of more than 70 years of age with an active oral substance without subjecting them to the sometimes severe adverse effect of the chemotherapy.

Timeline

Start
2006-06
Primary completion
2008-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule Intravenous
Subject Erlotinib Small molecule 150 mg Oral
Comparator Vinorelbine Small molecule 25 mg/m2 Intravenous