Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00281021 |
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Recruitment Status :
Terminated
(Interim analysis revealed that only 1 patient had a partial response.)
First Posted : January 24, 2006
Results First Posted : November 10, 2014
Last Update Posted : March 29, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carcinoma, Non-Small Cell Lung | Drug: Erlotinib plus Digoxin | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 26 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Erlotinib and Digoxin
Erlotinib plus Digoxin
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Drug: Erlotinib plus Digoxin
Each subject will receive erlotinib and digoxin daily until progression.
Other Names:
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- Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen. [ Time Frame: Measured every 6 weeks after baseline until disease progression, an average of 3 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281021
| Principal Investigator: | Goetz H Kloecker, MD, MSPH | James Graham Brown Cancer Center/ University of Louisville |
| Responsible Party: | Goetz Kloecker, Associate Professor, University of Louisville |
| ClinicalTrials.gov Identifier: | NCT00281021 |
| Other Study ID Numbers: |
629.05 BCC-LUN-05-001 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office ) |
| First Posted: | January 24, 2006 Key Record Dates |
| Results First Posted: | November 10, 2014 |
| Last Update Posted: | March 29, 2018 |
| Last Verified: | March 2018 |
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non-small cell lung cancer Erlotinib Digoxin |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Erlotinib Hydrochloride Digoxin Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Cardiotonic Agents Protective Agents Physiological Effects of Drugs |