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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00281021
Recruitment Status : Terminated (Interim analysis revealed that only 1 patient had a partial response.)
First Posted : January 24, 2006
Results First Posted : November 10, 2014
Last Update Posted : March 29, 2018
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Goetz Kloecker, University of Louisville

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small Cell Lung Drug: Erlotinib plus Digoxin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer
Study Start Date : February 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Erlotinib and Digoxin
Erlotinib plus Digoxin
Drug: Erlotinib plus Digoxin
Each subject will receive erlotinib and digoxin daily until progression.
Other Names:
  • Tarceva
  • Digitalis

Primary Outcome Measures :
  1. Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen. [ Time Frame: Measured every 6 weeks after baseline until disease progression, an average of 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281021

Sponsors and Collaborators
University of Louisville
James Graham Brown Cancer Center
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Principal Investigator: Goetz H Kloecker, MD, MSPH James Graham Brown Cancer Center/ University of Louisville
Additional Information:
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Responsible Party: Goetz Kloecker, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT00281021    
Other Study ID Numbers: 629.05
BCC-LUN-05-001 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office )
First Posted: January 24, 2006    Key Record Dates
Results First Posted: November 10, 2014
Last Update Posted: March 29, 2018
Last Verified: March 2018
Keywords provided by Goetz Kloecker, University of Louisville:
non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs