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

University of Louisville (UOFL)

Status and phase

Terminated

Phase 2

Conditions

Carcinoma, Non-Small Cell Lung

Treatments

Drug: Erlotinib plus Digoxin

Study type

Interventional

Funder types

Other

Identifiers

NCT00281021

629.05

BCC-LUN-05-001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)