Conditions: Lung Cancer
Keywords: stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IA non-small cell lung cancer stage IB non-small cell lung cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 42
Healthy volunteers: no

Brief summary:
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who are undergoing surgery for stage I, stage II, or stage III non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the effects of neoadjuvant gefitinib on downstream signaling pathways, including Src-Stat3, PI3K/Akt, ERK activity, and Bcl-2 family members in patients with resectable stage I-IIIA non-small cell lung cancer.
* Determine the effects of this drug on cell cycle and apoptosis within the primary tumor, by measuring changes in pre- and post-treatment Ki-67, Mcm2, cleaved caspase-3, and ApoTag, in these patients.

Secondary

* Determine the clinical response rate in patients treated with this drug.
* Determine the pathological response rate, defined as \> 95% necrosis or fibrosis in the pathological specimen, in patients treated with this drug.
* Determine the metabolic activity of this drug in these patients.
* Determine the safety, tolerability, and feasibility of this drug, in terms of toxicity and post-treatment resectability, in these patients.
* Correlate plasma and tumor concentrations of this drug with changes in post-treatment molecular markers in these patients.
* Identify a gene profile that predicts response to this drug in these patients.

OUTLINE: This is an open-label, pilot study.

Patients receive oral gefitinib once daily for 4 weeks in the absence of disease progression or unacceptable toxicity.

Within 3 days after completion of gefitinib, patients undergo restaging evaluation. Patients whose disease is still considered resectable proceed to surgery. Patients undergo thoracotomy with lobectomy or pneumonectomy OR sleeve resection. Patients also undergo mediastinal lymph node dissection. After surgical resection, treatment with gefitinib may continue off study at the discretion of the principal investigator.

After completion of study therapy, patients are followed at 30 days, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12.5 months.

Arms:
arm 1: The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.

At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.

Interventions: intervention 1: ZD1839
Intervention descriptions: intervention 1: None

Protocol document: