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 |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2004 |
| End Date: | September 2010 |
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.
- 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.
This is a phase II, single institution trial to correlate gefitinib response and mutations
in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted
in patients with Stage I and II NSCLC who have been determined to be operable and
resectable.
Patients must have 1 or more of the following features: never smoker or smoking history of <
15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be
enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery
(depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before
their operation. For patients that demonstrate a radiographic response to gefitinib
preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the
EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years
post-surgery. Patients who do not have evidence of radiographic response or mutations in the
protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study.
in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted
in patients with Stage I and II NSCLC who have been determined to be operable and
resectable.
Patients must have 1 or more of the following features: never smoker or smoking history of <
15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be
enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery
(depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before
their operation. For patients that demonstrate a radiographic response to gefitinib
preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the
EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years
post-surgery. Patients who do not have evidence of radiographic response or mutations in the
protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study.
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).
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