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Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by James Graham Brown Cancer Center, May 2008
Sponsors and Collaborators: James Graham Brown Cancer Center
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

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Digoxin
U.S. FDA Resources
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

Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • Computed tomography (CT) Scans of chest & abdomen will be done to evaluate therapeutic response [ Time Frame: at baseline, during cycles 3 & 5, and as needed after cycle 6 during 1-year follow-up period ] [ Designated as safety issue: No ]

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
1: Experimental
Erlotinib and Digoxin
Drug: Erlotinib plus Digoxin
Each subject will receive erlotinib and digoxin daily until progression.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of non-small cell lung cancer
  • measurable or evaluable disease
  • primary tumor must be documented by histopathic analysis
  • disease recurrences occurring greater than five years after original diagnosis must be biopsy proven
  • treatment with only one prior chemotherapy regimen for advanced disease (one additional prior regimen was allowed for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant therapy)
  • serum creatinine < 2mg/dl, or a calculated creatinine clearance > 40cc/min using the following formula: (140-age) x WT(kg) x 0.85 (if female 0.72) x creatinine (mg/dl). Tests must be done within 28 days prior to registration
  • must have a CT scan (chest & abdomen) within 4 weeks prior to registration
  • Zubrod performance status of 0-3

Exclusion Criteria:

  • women who are pregnant or nursing
  • no other prior malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
  • history of ventricular fibrillation, sinus node or AV nodal disease, Wolff Parkinson White Syndrome, evidence of congestive heart failure, chest pain with exertion, hemodynamically significant or life threatening cardiac arrhythmia, or evidence of prior myocardial infarction on EKG. EKG must have been done within 28 days prior to registration. A normal cardiac stress test within 182 days prior to registration is required for all patients over 50 years old or those with abnormal EKG or any history of cardiac disease.
  • hypersensitivity to erlotinib and/or Digoxin
  • abnormal levels of K, Mg, and/or Ca, or conditions which cause such abnormalities (e.g. malnutrition, severe diarrhea, prolonged vomiting, dialysis, GI suction, untreated hypothyroidism, and use of diuretics, amphotericin B, steroids, or antacids)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281021

Contacts
Contact: Jamie M Day, BSN (502) 562-3429 jmluka01@louisville.edu
Contact: Kate K Rodger, MSHCM, BSN (502) 562-3429 kkrodg01@louisville.edu

Locations
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            
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Goetz H Kloecker, MD, MSPH James Graham Brown Cancer Center/ University of Louisville
  More Information

James Graham Brown Cancer Center  This link exits the ClinicalTrials.gov site

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

Keywords provided by James Graham Brown Cancer Center:
non-small cell lung cancer
Erlotinib
Digoxin

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009