Carcinoma, Non-small-cell LungPhase 2NCT00125359
Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer
A Phase 2 study testing erlotinib and bexarotene in people with Carcinoma, Non-small-cell Lung, run by Konstantin Dragnev at 2 sites in United States.
Trial summary
The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer. Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of non-small-cell lung cancer (NSCLC). 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 and bexarotene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Mar 2014
- 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
- Advanced NSCLC
- Prior chemotherapy or radiotherapy is allowed.
Who cannot join
- Hepatic or renal dysfunction
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer
The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer.
Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.
Read the detailed description
This is a single institution open label phase II trial. Consecutive, eligible patients presenting with the diagnosis of advanced NSCLC are to be enrolled in this study. All eligible patients will receive continuous daily oral erlotinib 150 mg (Tarceva™) with daily bexarotene oral capsules 400 mg/m2 (Targretin®). The two agents will be taken at the same time. We anticipate the maximum accrual of 40 patients to this trial.
Patients will be evaluated by history, physical examination, and laboratory assessment every 4 weeks. Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and computer tomography every 8 weeks or longer if clinically indicated. Whole body PET scan will be obtained at 10 days and 8 weeks. All radiographic studies will be sent to Medical Metrix Solutions (MMS) for an independent radiographic review of tumor response.
- Conditions
- Carcinoma, Non-small-cell Lung
- Being tested
- erlotinib and bexarotene
- 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 and bexaroteneDrug
Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. Receives: Drug: erlotinib and bexarotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Response Rates
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Correlation of Early PET Responses With Objective Radiographic Responses.
PET response is assessed based on the guidelines of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group (Eur J Cancer 1999; 35(13):1773-82). PET response refers to the presence and measurement of the most current PET scan imaging when compared to baseline imaging. The amount of reduction in the disease from baseline to current imaging determines the extent to which the cancer has responded to treatment. Radiographic response is per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: Through study completion, an average of 1 year
Progression-free Survival and Overall Survival
Measured: Through study completion, an average of 1 year
Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionMar 2014
- Study completionMar 2014
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.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konstantin Dragnev
- Sponsor type
- University, hospital or other
- Collaborators
- Ligand Pharmaceuticals, Genentech, Inc.
- Responsible party
- Sponsor-investigator, Konstantin Dragnev, Dartmouth-Hitchcock Medical Center
- Investigators
- Konstantin H Dragnev, MD, Principal investigator, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125359
- Sponsor's protocol ID
- D-0440
- 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
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 Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00125359
- Acronym / sponsor ID
- D-0440
- Conditions
- Carcinoma, Non-small-cell Lung
- Keywords
- tarceva, targretin, non-small cell lung cancer, Carcinoma, non-small cell lung cancer, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Konstantin DragnevUniversity, hospital or other
- Collaborators
- Ligand Pharmaceuticals, Genentech, Inc.
- Study start
- Aug 2005
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (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.
The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer.
Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.
Detailed description
This is a single institution open label phase II trial. Consecutive, eligible patients presenting with the diagnosis of advanced NSCLC are to be enrolled in this study. All eligible patients will receive continuous daily oral erlotinib 150 mg (Tarceva™) with daily bexarotene oral capsules 400 mg/m2 (Targretin®). The two agents will be taken at the same time. We anticipate the maximum accrual of 40 patients to this trial.
Patients will be evaluated by history, physical examination, and laboratory assessment every 4 weeks. Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and computer tomography every 8 weeks or longer if clinically indicated. Whole body PET scan will be obtained at 10 days and 8 weeks. All radiographic studies will be sent to Medical Metrix Solutions (MMS) for an independent radiographic review of tumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: erlotinib and bexaroteneAll eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Advanced NSCLC
- Prior chemotherapy or radiotherapy is allowed.
Key exclusion criteria (1 listed)
- Hepatic or renal dysfunction
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 and bexaroteneDaily Erlotinib 150mg and daily bexarotene oral capsules 400mg. | Drug | 1 |
Primary outcome
Radiographic Response Rates
Time frame: Through study completion, an average of 1 year
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
3 secondary outcomes
Correlation of Early PET Responses With Objective Radiographic Responses.
Time frame: Through study completion, an average of 1 year
Progression-free Survival and Overall Survival
Time frame: Through study completion, an average of 1 year
Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses.
Time frame: Through study completion, an average of 1 year
Results and safety
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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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing erlotinib and bexarotene in people with Carcinoma, Non-small-cell Lung, run by Konstantin Dragnev at 2 sites 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 2 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 2 sites 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.
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 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?
Radiographic Response Rates (time frame: Through study completion, an average of 1 year). 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 8 Jan 2019.