Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC

Summary

ELIGIBILITY * Non-small cell lung cancer Clinical Stage 1A (T1N0M0 a tumor that is 3 cm or less in greatest dimension, surrounded by lung or visceral pleura, and without bronchoscopic evidence of invasion more proximal than the lobar bronchus (i.e., not in the main bronchus)\* or 1B (T2N0M0 a tumor with any of the following features of size or extent: More than 3 cm in greatest dimension. Involves the main bronchus, 2 cm or more distal to the carina. Invades the visceral pleura. Associated with atelectasis or obstructive pneumonitis that extends to the hilar region but does not involve the entire lung). * Must be deemed appropriate surgical candidate * ECOG performance status £ 2 * Age ³ 18 years * No prior chemotherapy, radiotherapy or EGFR inhibitors PRE-TREATMENT INVESTIGATIONS * History, physical examination, hematology, biochemistry, toxicity/baseline symptoms: within 7 days of registration * Radiology: CT chest within 7 days of registration * Tumor biopsy prior to treatment TREATMENT * Gefitinib 250 mg will be administered orally daily x 28 days EVALUATIONS ON TREATMENT * Physical examination (vital signs, weight, ECOG performance status) weekly x 4 * Hematology (CBC, differential): Day 1,15, 29 * Biochemistry (creatinine, electrolytes, bilirubin, alkaline phosphatase, AST/ALT, protein): Day 1,15, 29 * Radiology: CT at baseline and after day 28 * Toxicity evaluation: continuous DURATION OF TREATMENT * Treatment is to be discontinued in cases of serious or unacceptable toxicity, or by patient or physician request * Otherwise duration of therapy will be a maximum of 28 days

Timeline

Start

2005-01

Primary completion

2007-06

Completion

2009-11

Drugs

Indications