Carcinoma, Non-Small Cell LungPhase 2NCT00281021
Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer
A Phase 2 study testing Erlotinib plus Digoxin in people with Carcinoma, Non-Small Cell Lung, run by University of Louisville.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung
- What is being tested?
- Erlotinib plus Digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer
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.
- Conditions
- Carcinoma, Non-Small Cell Lung
- Being tested
- Erlotinib plus Digoxin
- Keywords
- non-small cell lung cancer, Erlotinib, Digoxin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib plus DigoxinDrug
Also called Tarceva, Digitalis
Each subject will receive erlotinib and digoxin daily until progression.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib and Digoxin | Experimental | Erlotinib plus Digoxin Receives: Drug: Erlotinib plus Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.
Measured: Measured every 6 weeks after baseline until disease progression, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Interim analysis revealed that only 1 patient had a partial response.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small Cell LungStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Goetz Kloecker, University of Louisville
- Investigators
- Goetz H Kloecker, MD, MSPH, Principal investigator, James Graham Brown Cancer Center/ University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281021
- Sponsor's protocol ID
- 629.05
- Other IDs
- BCC-LUN-05-001
- Status last verified
- Mar 2018
- First submitted
- 23 Jan 2006
- Last updated
- 29 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00281021
- Acronym / sponsor ID
- 629.05
- Conditions
- Carcinoma, Non-Small Cell Lung
- Keywords
- non-small cell lung cancer, Erlotinib, Digoxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis revealed that only 1 patient had a partial response.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Feb 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Jan 2006 (estimated)
- Results
- Posted 10 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib and Digoxin | Experimental | Drug: Erlotinib plus DigoxinErlotinib plus Digoxin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erlotinib plus DigoxinAlso: Tarceva, DigitalisEach subject will receive erlotinib and digoxin daily until progression. | Drug | Erlotinib and Digoxin |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- James Graham Brown Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goetz H Kloecker, MD, MSPH principal investigator
James Graham Brown Cancer Center/ University of Louisville
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib plus Digoxin in people with Carcinoma, Non-Small Cell Lung, run by University of Louisville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.