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.