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Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small Cell Lung

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Trial Information

Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Therapeutic response, evaluated by computed tomography (CT) scans of chest & abdomen.

Outcome Time Frame:

every 6 months until disease progression

Safety Issue:


Principal Investigator

Goetz H Kloecker, MD, MSPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center/ University of Louisville


United States: Institutional Review Board

Study ID:




Start Date:

February 2006

Completion Date:

December 2010

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • non-small cell lung cancer
  • Erlotinib
  • Digoxin
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms