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

This study has been terminated.
(Interim analysis revealed that only 1 patient had a partial response.)
Sponsor:
Collaborator:
University of Louisville
Information provided by:
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00281021
First received: January 23, 2006
Last updated: April 7, 2011
Last verified: April 2011
  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 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Therapeutic response, evaluated by computed tomography (CT) scans of chest & abdomen. [ Time Frame: every 6 months until disease progression ] [ Designated as safety issue: No ]

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:
  • Tarceva
  • Digitalis

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281021

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

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 24, 2014