Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC

NCT00188617 | Completed Phase 2 DMC

• 2 other identifiers: UHN REB04-0420-CASTRA ZENECA study D7913L00038
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

LUNG CANCER

Keywords

LUNG CANCER; IRESSA; GEFITINIB; STAGE 1A & 1B; NEOADJUVANT; PHASE 2

Outcome Measures

Primary Outcomes (1)

• · To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment

  before starting drug and after 28 days of treatment

Secondary Outcomes (1)

• · To assess the toxicity of neoadjuvant Gefitinib treatment in clinical stage 1A & 1B NSCLC

  at baseline, 2weeks into treatment at 4weeks and 30 days after stopping drug

Interventions

GEFITINIB DRUG

250 mg once a day for 28 days before surgery

Also known as: IRESSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• AstraZeneca: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Thomas Waddell, MD FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: November 1, 2009
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

CA (1)