Phase II Trial of Chronic Oral ZD1839 (Iressa®) (NSC-715055) in Both Previously-Untreated and Previously-Treated Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Overview
- Phase
- Phase 2
- Intervention
- gefitinib
- Conditions
- Bronchoalveolar Cell Lung Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Overall survival rate
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Phase II trial to study the effectiveness of gefitinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer
Detailed Description
PRIMARY OBJECTIVES: I. To assess the one-years survival rate in both previously-untreated and previously-treated patients with advanced bronchioalveolar carcinoma receiving chronic oral ZD1839. II. To assess the progression-free survival and overall survival in these groups of patients. III. To evaluate the frequency and severity of toxicities associated with this treatment regimen. IV. To evaluate the response rate using both the standard RECIST criteria and by computer-assisted image analysis in patients with measurable disease. V. To measure EGFR and EGFR variant III overexpression in tumor tissue samples and explore their relationship with aforementioned clinical outcomes. VI. To measure EGFR expression and activation status in slides of buccal brushings submitted on S9925 before and after initiation of treatment with ZD1839 and explore their association with response and survival. OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchioalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.) Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have a biopsy-proven, incompletely resected or unresectable bronchioloalveolar carcinoma, with pathology tissue available for central review and staining for EGFR and other molecular variables; fine needle aspirates, bronchial brushings or washings are not permitted for diagnosis; patients must have either selected stage IIIB due to cytology-confirmed malignant pleural effusion, or stage IV disease; tumors may be multi-focal or diffuse
- •Patients must have evidence of disease by CT scan of the chest; the pre-study CT scan of the chest must include the liver and adrenal glands or be accompanied by an abdominal CT scan in which they are visualized; all x-rays/scans to assess measurable disease must have performed within 28 days prior to registration; all other required tests to assess non-measurable disease must have been performed within 42 days prior to registration
- •The institution must plan to submit all pathology materials (i.e., H\&E stained slide from each block, plus 10 unstained slide from one block) within 30 days after registration
- •All patients must have a Zubrod performance status of 0-2
- •Patients must not have received prior treatment with biologic therapies that target EGFR; patients may not be currently receiving or planning to receive any other treatment directed at the BAC
- •Prior biologic therapy, chemotherapy and radiotherapy are allowed, provided that at least four weeks have elapsed since last treatment with these modalities and the patient's disease has been assessed since completing previous treatment; disease must be present outside of areas of previous radiation therapy
- •Prior surgery is allowed, provided that the patient has had sufficient recovery time from surgery, as determined by the enrolling physician
- •Patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation; patients must not have had prior surgical procedures affecting absorption
- •Serum bilirubin =\< 1.5 x the institutional upper limit of normal
- •SGOT or SGPT =\< 2.5 x the institutional upper limit of normal (IULN) (if liver metastases are present; SGOT/SGPT =\< 5 IULN allowed)
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (gefitinib)
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Intervention: gefitinib
Treatment (gefitinib)
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Overall survival rate
Time Frame: Up to 1 year
Secondary Outcomes
- Progression-free survival(From the date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 2 years)
- Change in EGFR and EGFR variant III overexpression and their relationship with survival(From baseline to up to 1 year)
- Response via CAIA versus response by RECIST(At 16 weeks)
- Toxicity as assessed by CTCAE version 3.0(Up to 30 days after completion of study treatment)