Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to:

• see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery

• see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene

• see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene

• see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment.

• see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Gefitinib

Criteria

Inclusion Criteria:

• Pathologic confirmation of malignancy at Memorial Sloan-Kettering

• Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0, T3N0M0) and 1 of the following features: never smoker or < 15 pack year smoking history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or adenocarcinoma with BAC features)

• Patients must have been determined to be operable and resectable by the treating thoracic surgeon.

• Age >18 years.

• Measurable indicator lesions

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Pregnant or lactating women or women of childbearing potential not using effective contraception. Men participating in the trial must also use effective contraception when sexually active.

• Patients may not be receiving any other investigational agents.

• Any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).