Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Gefitinib

Criteria

DISEASE CHARACTERISTICS:

• Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer

• pN2 disease proven by mediastinoscopy

• Meets any of the following criteria:

• Never smoked

• EGFR mutations (in exon 18, 19, or 21)*

• FISH positive for EGFR* NOTE: *Irrespective of smoking history

• Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan, according to RECIST

• Feasible to undergo pneumonectomy or lobectomy

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-1

• FEV_1 ≥ 2.0 L in preoperative pulmonary function test

• Hemoglobin ≥ 9.0 g/dL

• WBC 4,000-12,000/μL

• ANC ≥ 1,500/μL

• Platelet count ≥ 100,000/mm³

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 3.0 times ULN

• AST and ALT ≤ 3.0 times ULN

• Creatinine ≤ 1.5 times ULN

• Negative pregnancy test

Exclusion criteria:

• Severe complications or infections

• Pregnant or breast-feeding women

• Clinically significant heart disease

• Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus

• Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy, chemotherapy, hormone therapy, or target therapy

• No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy