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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Non-small Cell Lung Cancer, Bronchioloalveolar Cancer

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Trial Information

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


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.


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To correlate the radiographic response to gefitinib with the presence of mutations in the protein-tyrosine kinase domain of the EGF receptor gene in tumor specimens obtained before treatment with gefitinib.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Naiyer Rizvi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-071

NCT ID:

NCT00588445

Start Date:

June 2004

Completion Date:

September 2010

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Bronchioloalveolar Cancer
  • Lung Cancer
  • Non-small cell lung cancer
  • Gefitnib
  • Cancer
  • NSCLC
  • bronchioloalveolar cancer
  • smoker
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021