Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer
Condition: Carcinoma, Non-Small Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib plus Digoxin
Intervention description: Each subject will receive erlotinib and digoxin daily until progression.
Intervention MeSH terms: Erlotinib Hydrochloride; Digoxin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-small cell lung cancer; Erlotinib; Digoxin

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.
    

Eligibility 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)