Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer

Carcinoma, Non-Small Cell Lung Clinical Trial

Official title: Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine the potential benefit of adding Digoxin to erlotinib (Tarceva) treatment for patients with non-small cell lung cancer.

Clinical Trial Description

Non-small cell lung cancer (NSCLC) accounts for 80% of all lung cancer cases. The majority of NSCLC patients have advanced disease at the time of diagnosis, which usually requires treatment beyond standard first-line chemotherapy. Until recently, patients were limited in the number of options available for second-line treatment of NSCLC. In 2004, erlotinib was approved by the FDA for second and third-line treatment of NSCLC. Erlotinib is a cancer chemotherapy medication that slows the growth and spread of cancer cells in the body.

Recent research suggests that a medication called Digoxin can sensitize cancer cells to respond better to chemotherapy. Digoxin is normally used to treat certain heart conditions by helping the heart beat more strongly and regularly and is not approved by the FDA for the treatment of NSCLC. Investigators hope that subject response rates to standard erlotinib therapy will be significantly improved by the addition of Digoxin.

The purpose of this study is to determine the tumor response rate and overall survival of patients with non-small cell lung cancer treated with a daily regimen of erlotinib (Tarceva) plus Digoxin. ;

Related Conditions & MeSH terms

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

• NCT number: NCT00281021
• Study type: Interventional
• Source: University of Louisville
• Status: Terminated
• Phase: Phase 2
• Start date: February 2006
• Completion date: December 2010