NCT00087269

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

July 8, 2004

Last Update Submit

June 4, 2013

Conditions

Stage IA Non-small Cell Lung CancerStage IB Non-small Cell Lung CancerStage IIA Non-small Cell Lung CancerStage IIB Non-small Cell Lung CancerStage IIIA Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Biochemical response rate in tumor defined as > 75% decrease in P-MAPK and/or P-AKT

    Up to 5 years

Secondary Outcomes (1)

  • Tolerability of erlotinib, graded according to the NCI CTCAE version 3.0

    Up to 5 years

Study Arms (1)

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.

Drug: erlotinib hydrochlorideProcedure: therapeutic endoscopic surgeryOther: laboratory biomarker analysis

Interventions

erlotinib hydrochlorideDRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774
Treatment (erlotinib)
therapeutic endoscopic surgeryPROCEDURE

Undergo surgical resection

Treatment (erlotinib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (erlotinib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Steven Keller

    Eastern Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

December 1, 2004

Primary Completion

April 1, 2006

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

US(1)