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| Sponsor: | James Graham Brown Cancer Center |
|---|---|
| Collaborator: |
University of Louisville |
| Information provided by: | James Graham Brown Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00281021 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small Cell Lung |
Drug: Erlotinib plus Digoxin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer |
| Enrollment: | 26 |
| Study Start Date: | February 2006 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Erlotinib and Digoxin
Erlotinib plus Digoxin
|
Drug: Erlotinib plus Digoxin
Each subject will receive erlotinib and digoxin daily until progression.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Goetz H Kloecker, MD, James Graham Brown Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00281021 History of Changes |
| Other Study ID Numbers: | 629.05, BCC-LUN-05-001 |
| Study First Received: | January 23, 2006 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
non-small cell lung cancer Erlotinib Digoxin |
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Digoxin Erlotinib Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Protective Agents Physiological Effects of Drugs Protein Kinase Inhibitors |