CClinicalTrials.gg
TerminatedNCT00281021Updated Mar 29, 2018Results posted

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

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

Why this study was terminated
Interim analysis revealed that only 1 patient had a partial response.
Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Carcinoma, Non-Small Cell Lung

Keywords

  • non-small cell lung cancer
  • Erlotinib
  • Digoxin
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In context

Lung Neoplasms

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Erlotinib and Digoxin

    Erlotinib plus Digoxin

    Drug: Erlotinib plus Digoxin

Interventions

  • DrugErlotinib plus Digoxin

    Each subject will receive erlotinib and digoxin daily until progression.

    Also known as: Tarceva, Digitalis

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Nov 10, 2014

Participant flow

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.

Participant flow — Overall Study
MilestoneErlotinib and Digoxin
Started26
Completed24
Not completed2

Outcome measures

PrimaryTherapeutic 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
Reported as:
Number · participants
Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.
participantsErlotinib and Digoxin
Partial Response1
Stable Disease9
Progressive Disease14

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Erlotinib and Digoxin—0/24 (0%)20/24 (83.3%)
Most frequent other events
Most frequent other events
EventErlotinib and Digoxin
DiarrheaGastrointestinal disorders13/24
RashGeneral disorders10/24
FatigueGeneral disorders5/24
NauseaGastrointestinal disorders3/24
DyspneaRespiratory, thoracic and mediastinal disorders2/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)Erlotinib and Digoxin
Mean61 (34 to 78)
Age, Customized
Age, Customized(participants)Erlotinib and Digoxin
<=18 years0
>18 years26
Sex: Female, Male
Sex: Female, Male(Participants)Erlotinib and Digoxin
Female16
Male10
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Study locations

No study locations are listed for this record.

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References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00281021
Lead sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center
Responsible party
Goetz Kloecker (Associate Professor, University of Louisville) — Principal investigator
First posted
Jan 24, 2006
Start date
Feb 2006
Primary completion
Dec 2010
Completion
Dec 2010
Results posted
Nov 10, 2014
Last update
Mar 29, 2018

Study contacts

Goetz H Kloecker, MD, MSPH
principal investigator · James Graham Brown Cancer Center/ University of Louisville

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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