Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene
Completed · Phase 2
Conditions studied: Lung Cancer, Non-small Cell Lung Cancer, Bronchioloalveolar Cancer
In brief
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.
Key facts
- Study ID
- NCT00588445
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 65
- Starts
- 2004-06-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2016-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.