Overview

Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Health Network, Toronto
Collaborator:
AstraZeneca
Treatments:
Gefitinib
Criteria
Inclusion Criteria:

- Patients must have biopsy-proven non-small cell lung carcinoma (NSCLC) or a lung
nodule seen on CT imaging and a high-clinical suspicion of NSCLC

- 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

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- Patients who have received prior anticancer treatment with chemotherapy, radiotherapy
or EGFR inhibitor therapy;

- Patients who have had a previous diagnosis of cancer, are excluded except if have been
adequately treated for non-melanoma skin cancer or carcinoma in situ of the cervix are
eligible irrespective of when that treatment was given.

- Patients may not be receiving any other investigational or anticancer agents while on
study;

- History of allergic reactions to Gefitinib or erlotinib

- Pre-existing diarrhea ³ NCI CTC Grade 2

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure or evidence of cardiac dysfunction,
unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, poorly
controlled diabetes mellitus, clinically significant or untreated ophthalmologic (e.g.
Sjogrens etc.) or gastrointestinal conditions (e.g. Crohns disease, ulcerative
colitis) or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women because of the unknown effects of Gefitinib on the human fetus.

- HIV-positive patients on active treatment

- Active malignancy at any other site including combined small cell and non-small cell
carcinomas or a pulmonary carcinoid tumor.

- Taking drugs that induce CYP3A4 enzymes, patients with ongoing use of phenytoin,
rifampicin, carbamazepine, barbiturates, rifampicin, or St John's Wort are excluded.

- Incomplete healing from previous surgery.

- Use of any agent that decreases gastric pH, including proton pump inhibitors,
Histamine-2 receptor blockers or sodium bicarbonate. Use of calcium or magnesium based
elixirs are not included.