Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC
Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
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