Lung CancerPhase 2NCT00585533
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Erlotinib (Tarceva) in people with Lung Cancer, run by University of Utah at 1 site in United States.
Trial summary
This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Erlotinib (Tarceva)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Mar 2012
- 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
- Performance status 0-1.
- Weight Loss < 10% in preceding 3 months
- Age 18 years and older.
- Adjuvant chemotherapy allowed if > 6 months from protocol entry
- Adequate Organ Function
- Liver enzymes < 2X normal, bilirubin = normal
- Oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer related)
- Creatinine <2.0 mg
Who cannot join
- Not pregnant or lactating.
- No Clinical Brain Metastases
- No prior chemotherapy for systemic disease
- Imminent need for chemotherapy for impending organ dysfunction is not allowed
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.
Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.
Read the detailed description
Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC
Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)
- Conditions
- Lung Cancer
- Being tested
- Erlotinib (Tarceva)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib (Tarceva)Drug
Also called Tarceva
Erlotinib
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Not described Receives: Drug: Erlotinib (Tarceva) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.
Measured: 6 months
Secondary outcomes (1)
Overall Survival
Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startJun 2004
- Primary completionMar 2012
- Study completionMar 2012
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wallace Akerley, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585533
- Sponsor's protocol ID
- HCI12555
- Other IDs
- IRB# 00012555
- Status last verified
- Jul 2013
- First submitted
- 26 Dec 2007
- Last updated
- 30 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00585533
- Acronym / sponsor ID
- HCI12555
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Posted 21 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.
Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.
Detailed description
Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC
Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: Erlotinib (Tarceva) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Performance status 0-1.
- Weight Loss < 10% in preceding 3 months
- Age 18 years and older.
- Adjuvant chemotherapy allowed if > 6 months from protocol entry
- Adequate Organ Function
Key exclusion criteria (4 listed)
- Not pregnant or lactating.
- No Clinical Brain Metastases
- No prior chemotherapy for systemic disease
- Imminent need for chemotherapy for impending organ dysfunction is not allowed
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)Also: TarcevaErlotinib | Drug | A |
Primary outcome
Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
Time frame: 6 months
Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.
1 secondary outcome
Overall Survival
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- 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.
Wallace Akerley, MD principal investigator
University of Utah
1 site 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 (Tarceva) in people with Lung Cancer, run by University of Utah 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 8 inclusion and 4 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 30 Jul 2013. 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.
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 21 Nov 2012). 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?
Survival Rate at 6-months Chemotherapy-progression-free (CP-free) (time frame: 6 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 30 Jul 2013.