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Sponsors and Collaborators: |
James Graham Brown Cancer Center University of Louisville |
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Information provided by: | James Graham Brown Cancer Center |
ClinicalTrials.gov Identifier: | NCT00281021 |
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 |
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Carcinoma, Non-Small Cell Lung |
Drug: Erlotinib plus Digoxin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer |
Estimated Enrollment: | 43 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2016 |
Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Erlotinib and Digoxin
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Drug: Erlotinib plus Digoxin
Each subject will receive erlotinib and digoxin daily until progression.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jamie M Day, BSN | (502) 562-3429 | jmluka01@louisville.edu |
Contact: Kate K Rodger, MSHCM, BSN | (502) 562-3429 | kkrodg01@louisville.edu |
United States, Kentucky | |
James Graham Brown Cancer Center | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Jamie M Day, BSN 502-562-3429 jmluka01@louisville.edu | |
Principal Investigator: Goetz H Kloecker, MD, MSPH | |
Sub-Investigator: Donald M Miller, MD, PhD | |
Sub-Investigator: Damian Laber, MD | |
Sub-Investigator: Dharamvir Jain, MD | |
Sub-Investigator: Vivek Sharma, MD | |
Sub-Investigator: Fred Hendler, MD, PhD |
Principal Investigator: | Goetz H Kloecker, MD, MSPH | James Graham Brown Cancer Center/ University of Louisville |
Responsible Party: | James Graham Brown Cancer Center ( Goetz H Kloecker, MD ) |
Study ID Numbers: | 629.05, BCC-LUN-05-001 |
Study First Received: | January 23, 2006 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00281021 |
Health Authority: | United States: Institutional Review Board |
non-small cell lung cancer Erlotinib Digoxin |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Digoxin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents |
Protein Kinase Inhibitors Protective Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Anti-Arrhythmia Agents |