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

NCT00281021 | Terminated Phase 2 Results DMC

• 2 other identifiers: 629.05BCC-LUN-05-001
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

non-small cell lung cancer; Erlotinib; Digoxin

Outcome Measures

Primary Outcomes (1)

• Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.

  Measured every 6 weeks after baseline until disease progression, an average of 3 months

Study Arms (1)

Erlotinib and Digoxin

EXPERIMENTAL

Erlotinib plus Digoxin

Drug: Erlotinib plus Digoxin

Interventions

Erlotinib plus Digoxin DRUG

Each subject will receive erlotinib and digoxin daily until progression.

Also known as: Tarceva, Digitalis

Erlotinib and Digoxin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Related Links

• James Graham Brown Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Digoxin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Goetz Kloecker
• Organization: James Graham Brown Cancer Center, University of Louisville

ghkloe01@exchange.louisville.edu

502-562-4358

Study Officials

• Goetz H Kloecker, MD, MSPH

  James Graham Brown Cancer Center/ University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2006
• First Posted: January 24, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 29, 2018
• Results First Posted: November 10, 2014

Record last verified: 2018-03