Carcinoma, Non-small-cell LungNCT00125372

Study of Tarceva and Targretin in Stage I-II Lung Cancer

A study testing erlotinib (Tarceva) and bexarotene (Targretin) in people with Carcinoma, Non-small-cell Lung, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. 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 (Tarceva) and bexarotene (Targretin)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Dec 2005to Aug 2010
Phase: Interventional
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

Resectable stage I or II non-small-cell lung cancer
Prior tissue biopsy (not cytology) available for research analysis
Adequate hepatic and renal function

Who cannot join

Prior chemotherapy or radiotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer

Read the detailed description

Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.

Conditions: Carcinoma, Non-small-cell Lung
Being tested: erlotinib (Tarceva) and bexarotene (Targretin)
Keywords: tarceva, targretin, non-small cell lung cancer, carcinoma, non-small cell lung cancer, nsclc
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

erlotinib (Tarceva) and bexarotene (Targretin)Drug
Also called Tarceva, Targretin
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy

Study groups in NCT00125372
Study group	Role	What they receive
Erlotinib and Bexarotene	Experimental	Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. Receives: Drug: erlotinib (Tarceva) and bexarotene (Targretin)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Change in Expression Level of EGFR.
Measured: Baseline and 9 days
Number of Participants With Change in Expression Level of Cyclin D1
Measured: Baseline and 9 days
Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
Measured: Baseline and 9 days

Secondary outcomes (2)

Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels
Measured: At 9 days
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
Measured: Baseline and 9 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Aug 2010

First posted1 Aug 2005 (estimated)
Study startDec 2005
Primary completionAug 2010
Study completionAug 2010

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 Dartmouth-Hitchcock Medical CenterThe 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00125372
Sponsor's protocol ID: D-0453
Status last verified: Dec 2018
First submitted: 29 Jul 2005
Last updated: 8 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00125372
Acronym / sponsor ID: D-0453
Conditions: Carcinoma, Non-small-cell Lung
Keywords: tarceva, targretin, non-small cell lung cancer, carcinoma, non-small cell lung cancer, nsclc
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: Ligand Pharmaceuticals, Genentech, Inc.
Study start: Dec 2005
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 1 Aug 2005 (estimated)
Results: Posted 13 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 Bexarotene	Experimental	Drug: erlotinib (Tarceva) and bexarotene (Targretin)Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Resectable stage I or II non-small-cell lung cancer
Prior tissue biopsy (not cytology) available for research analysis
Adequate hepatic and renal function

Key exclusion criteria (1 listed)

Prior chemotherapy or radiotherapy

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 (Tarceva) and bexarotene (Targretin)Also: Tarceva, TargretinErlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy	Drug	Erlotinib and Bexarotene

Primary outcome

Number of Participants With Change in Expression Level of EGFR.
Time frame: Baseline and 9 days
Number of Participants With Change in Expression Level of Cyclin D1
Time frame: Baseline and 9 days
Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
Time frame: Baseline and 9 days

2 secondary outcomes

Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels
Time frame: At 9 days
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
Time frame: Baseline and 9 days

Results and safety

Results posted to the registry on 13 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erlotinib and Bexarotene	12	10

Primary outcome: Number of Participants With Change in Expression Level of EGFR.

Time frame: Baseline and 9 days. Count of participants. Unit: Participants

Measure	Erlotinib and Bexarotene n = 10
Reduction in EGFR expression	3
No change	7

Primary outcome: Number of Participants With Change in Expression Level of Cyclin D1

Time frame: Baseline and 9 days. Count of participants. Unit: Participants

Measure	Erlotinib and Bexarotene n = 10
Reduction in Cyclin D1 expression	6
No change	4

Primary outcome: Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)

Time frame: Baseline and 9 days. Count of participants. Unit: Participants

Measure	Erlotinib and Bexarotene n = 10
Reduction in pEGFR expression	6
No change	4

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for each patient at the start of study treatment until 4 weeks following surgical resection. The total time of adverse event collection over the course of the study from the first treated subject to the last treated patient's end-of-study visit was 4 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erlotinib and Bexarotene	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
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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.

Konstantin H Dragnev, MD principal investigator

Norris Cotton Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing erlotinib (Tarceva) and bexarotene (Targretin) in people with Carcinoma, Non-small-cell Lung, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2018). 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?

Number of Participants With Change in Expression Level of EGFR. (time frame: Baseline and 9 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00125372.

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 8 Jan 2019.