Official Title: “Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2016

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Erlotinib and Digoxin

Primary 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
    Safety Issue?: 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: James Graham Brown Cancer Center

Overall Clinical Trial Officials and Contacts

Goetz H Kloecker, MD, MSPH Principal Investigator James Graham Brown Cancer Center/ University of Louisville  

Overall Contact: Jamie M Day, BSN (502) 562-3429 jmluka01@louisville.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00281021

Study ID Number: 629.05

ClinicalTrials.gov Identifier: NCT00281021

Health Authority: United States: Institutional Review Board

James Graham Brown Cancer Center