Lung Cancer Clinical Trial
Official title:
Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene in Patients With NSCLC
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Radiographic Response to Gefitinib | Radiographic response is defined as a minor response ( > 25% decrease in the sum of the products of measured lesions) | 21 days | No |
Secondary | Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data | Each patient provides two binary variables: presence/absence of mutation and responder/non responder. The association between the two will be tested using the Fisher's exact test for the resulting 2x2 table.Changes in expression levels within a patient will be assessed using a paired t-test. Similarly differences in expression levels between responders and non-responders will be assessed using a two-sample t-test. Appropriate adjustment will be made for the multiple comparisons problem that arises because there are over 21,000 probe sets on the U133A array. | 2 years | Yes |
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