A Phase 2 interventional study of Erlotinib plus Digoxin in Carcinoma, Non-Small Cell Lung, sponsored by University of Louisville. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by University of Louisville · Phase 2, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Erlotinib plus Digoxin
Drug: Erlotinib plus Digoxin
Each subject will receive erlotinib and digoxin daily until progression.
Also known as: Tarceva, Digitalis
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
Patient accrual lasted from March 2006 until August 2008 and was stopped early at the time of interim analysis. 24 who completed at least 6 weeks of therapy are presented here.
| Milestone | Erlotinib and Digoxin |
|---|---|
| Started | 26 |
| Completed | 24 |
| Not completed | 2 |
| participants | Erlotinib and Digoxin |
|---|---|
| Partial Response | 1 |
| Stable Disease | 9 |
| Progressive Disease | 14 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib and Digoxin | — | 0/24 (0%) | 20/24 (83.3%) |
| Event | Erlotinib and Digoxin |
|---|---|
| DiarrheaGastrointestinal disorders | 13/24 |
| RashGeneral disorders | 10/24 |
| FatigueGeneral disorders | 5/24 |
| NauseaGastrointestinal disorders | 3/24 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/24 |
| Age, Continuous(years) | Erlotinib and Digoxin |
|---|---|
| Mean | 61 (34 to 78) |
| Age, Customized(participants) | Erlotinib and Digoxin |
|---|---|
| <=18 years | 0 |
| >18 years | 26 |
| Sex: Female, Male(Participants) | Erlotinib and Digoxin |
|---|---|
| Female | 16 |
| Male | 10 |
No study locations are listed for this record.
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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