Stage IA Non-small Cell Lung CancerPhase 2NCT00087269

Erlotinib in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer Undergoing Surgical Resection

A Phase 2 study testing erlotinib hydrochloride, therapeutic endoscopic surgery and laboratory biomarker analysis in people with Stage IA Non-small Cell Lung Cancer and Stage IB Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This phase II trial is studying how well erlotinib works in treating patients with stage I, stage II, or stage IIIA non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib before surgery may shrink the tumor so that it can be removed. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer
What is being tested?: erlotinib hydrochloride, therapeutic endoscopic surgery and laboratory biomarker analysis
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteUnited States
Study dates: Dec 2004to Apr 2006
Phase: Phase 2
Are there results?: None posted in the registry

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

Patients with suspicion of lung cancer without distant metastases
Patients are scheduled to have a tissue diagnostic procedure within 3 to 5 days of pre-registration
Patients are willing to allow collection and submission of baseline and post-therapy tumor tissue, skin and blood samples for this study
Patients must have ECOG performance status of 0, 1, or 2
Patients must have no psychological, familial, sociological, or geographic conditions that will interfere with medical follow-up and compliance with the study protocol
Patients must have no prior chemotherapy or radiation therapy or no prior anti- EGFR treatment exposure

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Patients must be able to take oral medication and not have malabsorption syndrome, or prior gastrointestinal surgery that limits their absorption (i.e. requiring total parental nutrition)
Patients must not be using phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, oxcarbazepine, rifapentine, St John's Wort, or any other CYP 3A4 enzyme-inducing agent; any use of these substances must be discontinued at least 2 weeks prior to registration
Patients must not be taking any anti-coagulants
Patients must not have been treated with a non-approved or investigational drug within 21 days prior to pre-registration; patients must not have serious underlying medical condition that would impair the ability of patient to receive the planned treatment
Patients with a known hypersensitivity to OSI-774 (erlotinib) are not eligible
Patients must have histologically confirmed NSCLC; cytologic specimens obtained by brushing, washing or needle aspiration of defined lesions will be acceptable
Patients must have stage IA (T1N0M0), stage IB (T2N0M0), stage IIA (T1N1M0), stage IIB (T2N1M0; T3N0-1M0), or stage IIIA (T1-3N2M0) disease
Patients with small cell component on histology specimen are not eligible
A paraffin-embedded cell block and 1-2 segments of frozen tissue demonstrating NSCLC and obtained during the diagnostic biopsy is available for submission
Patients must be considered operable candidates and disease must be considered resectable
Pregnant or breastfeeding women are excluded from the study because the agents used in this study may be teratogenic to a fetus or child and there is no information on the excretion of the agents or their metabolites into breast milk
All females of childbearing potential must have a blood test or urine study within 1 week, prior to registration to rule out pregnancy
Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
WBC >= 3500/mm^3
ANC >= 1500/mm^3
Platelet count >= 100,000/mm^3
Total bilirubin < 1.5mg/dL
SGPT and SGOT < 3 times institution's upper limit of normal
Serum creatinine < 2mg/dl or creatinine clearance >= 20 ml/min

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Phase II Study to Evaluate the Tumor Biochemical Effects of the EGFR Tyrosine Kinase Inhibitor OSI-774 (Erlotinib) Administered Prior to Surgical Resection in Patients With Early Stage Non-Small Cell Lung Cancer

Read the detailed description

PRIMARY OBJECTIVES:

To determine the biochemical response rate (> 75% decrease in P-MAPK and/or P-AKT) with daily oral OSI-774 (erlotinib) for 14 consecutive days in patients with early stage, operable NSCLC.

SECONDARY OBJECTIVES:

To evaluate the safety and tolerance of daily oral OSI-774 (erlotinib) as pre-operative treatment for early stage operable NSCLC.

TERTIARY OBJECTIVES:

To correlate antiproliferative (Ki-67, p27) and apoptotic (TUNEL assay) tumor responses to OSI-774 (erlotinib) with pre-therapy tumor and skin EGFR pathway functional status and post-therapy tumor and skin EGFR pathway inhibition in patients with resectable NSCLC treated preoperatively with OSI-774 (erlotinib) for 14 days.

II. Assessment of functional EGFR status: HER1, HER-2, HER3, HER4, PHER1, AKT, P-AKT, MAPK-P-MAPK, STAT-3, P-STAT-3, EGFR-III by immunohistochemistry (IHC).

III. Assessment of proliferative response: Ki67 and p27 by IHC. IV. Assessment of apoptotic response: TUNEL assay. V. To study the role of the gastrin-releasing factor and estrogen receptor pathways in the sensitivity and resistance of NSCLC to OSI-774 (erlotinib).

VI. To identify patterns of gene and protein expression pre-therapy and post-therapy that are associated with tumor clinical, biochemical, antiproliferative, and apoptotic responses.

VII. To study the antitumor activity of OSI-774 (erlotinib) in NSCLC tumors heterotransplanted in nude mice after surgical resection and to investigate the sequential molecular changes associated with tumor response to OSI-774 (erlotinib) therapy.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity. Patients then undergo surgical resection on the last day of study drug administration (day 14 or day 21). Patients may receive chemotherapy and/or radiotherapy after surgical resection at the discretion of the primary physician.

Patients are followed for 5 years after study registration.

Conditions: Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
Being tested: erlotinib hydrochloride, therapeutic endoscopic surgery, laboratory biomarker analysis
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 hydrochlorideDrug
Also called CP-358,774, erlotinib, OSI-774
Given orally
therapeutic endoscopic surgeryProcedure or surgery
Undergo surgical resection
laboratory biomarker analysisOther
Correlative studies

Study groups in NCT00087269
Study group	Role	What they receive
Treatment (erlotinib)	Experimental	Patients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity. Patients then undergo surgical resection on the last day of study drug administration (day 14 or day 21). Patients may receive chemotherapy and/or radiotherapy after surgical resection at the discretion of the primary physician. Receives: Drug: erlotinib hydrochloride; Procedure: therapeutic endoscopic surgery; Other: laboratory biomarker analysis

What is being measured

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

Biochemical response rate in tumor defined as > 75% decrease in P-MAPK and/or P-AKT
Measured: Up to 5 years

Secondary outcomes (1)

Tolerability of erlotinib, graded according to the NCI CTCAE version 3.0
Measured: Up to 5 years

Timeline

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

Dec 2004Apr 2006

First posted12 Jul 2004 (estimated)
Study startDec 2004
Primary completionApr 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stage IA Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The 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: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00087269
Sponsor's protocol ID: NCI-2012-02950
Other IDs: E4503, U10CA021115
Status last verified: Jun 2013
First submitted: 8 Jul 2004
Last updated: 6 Jun 2013
Results posted: No

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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All Stage IA Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study to Evaluate the Tumor Biochemical Effects of the EGFR Tyrosine Kinase Inhibitor OSI-774 (Erlotinib) Administered Prior to Surgical Resection in Patients With Early Stage Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00087269
Acronym / sponsor ID: NCI-2012-02950
Conditions: Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 110 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Dec 2004
Primary completion: Apr 2006 (actual)
First posted: 12 Jul 2004 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

PRIMARY OBJECTIVES:

To determine the biochemical response rate (> 75% decrease in P-MAPK and/or P-AKT) with daily oral OSI-774 (erlotinib) for 14 consecutive days in patients with early stage, operable NSCLC.

SECONDARY OBJECTIVES:

To evaluate the safety and tolerance of daily oral OSI-774 (erlotinib) as pre-operative treatment for early stage operable NSCLC.

TERTIARY OBJECTIVES:

To correlate antiproliferative (Ki-67, p27) and apoptotic (TUNEL assay) tumor responses to OSI-774 (erlotinib) with pre-therapy tumor and skin EGFR pathway functional status and post-therapy tumor and skin EGFR pathway inhibition in patients with resectable NSCLC treated preoperatively with OSI-774 (erlotinib) for 14 days.

II. Assessment of functional EGFR status: HER1, HER-2, HER3, HER4, PHER1, AKT, P-AKT, MAPK-P-MAPK, STAT-3, P-STAT-3, EGFR-III by immunohistochemistry (IHC).

VI. To identify patterns of gene and protein expression pre-therapy and post-therapy that are associated with tumor clinical, biochemical, antiproliferative, and apoptotic responses.

OUTLINE: This is a multicenter study.

Patients are followed for 5 years after study registration.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (erlotinib)	Experimental	Drug: erlotinib hydrochloride, Procedure: therapeutic endoscopic surgery, Other: laboratory biomarker analysisPatients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity. Patients then undergo surgical resection on the last day of study drug administration (day 14 or day 21). Patients may receive chemotherapy and/or radiotherapy after surgical resection at the discretion of the primary physician.

Who may qualify

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

Key inclusion criteria (25 listed)

Patients with suspicion of lung cancer without distant metastases
Patients are scheduled to have a tissue diagnostic procedure within 3 to 5 days of pre-registration
Patients are willing to allow collection and submission of baseline and post-therapy tumor tissue, skin and blood samples for this study
Patients must have ECOG performance status of 0, 1, or 2
Patients must have no psychological, familial, sociological, or geographic conditions that will interfere with medical follow-up and compliance with the study protocol

Key exclusion criteria (0 listed)

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 hydrochlorideAlso: CP-358,774, erlotinib, OSI-774Given orally	Drug	Treatment (erlotinib)
therapeutic endoscopic surgeryUndergo surgical resection	Procedure or surgery	Treatment (erlotinib)
laboratory biomarker analysisCorrelative studies	Other	Treatment (erlotinib)

Primary outcome

Biochemical response rate in tumor defined as > 75% decrease in P-MAPK and/or P-AKT
Time frame: Up to 5 years

1 secondary outcome

Tolerability of erlotinib, graded according to the NCI CTCAE version 3.0
Time frame: Up to 5 years

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.

Related trials for Stage IA Non-small Cell Lung Cancer

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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.

Steven Keller principal investigator

Eastern Cooperative Oncology Group

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

Questions about this trial

What is this clinical trial studying?

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 25 inclusion and 0 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 6 Jun 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?

The study was stopped early. Results are not available in the source record.

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?

Biochemical response rate in tumor defined as > 75% decrease in P-MAPK and/or P-AKT (time frame: Up to 5 years). 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 NCT00087269.

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 6 Jun 2013.