Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PRIMARY OBJECTIVES: I. Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer. SECONDARY OBJECTIVES: I. Determine the duration of response in patients treated with this regimen. II. Determine the toxicity of this treatment regimen in this patient population. III. Assess levels of circulating HER2 and correlate with HER2 expression in this patient population. V. Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression. OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression or death. PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Given IV
Correlative studies
Cancer and Leukemia Group B
Chicago, Illinois, United States
Response rate (complete response [CR] and partial response [PR])
Time frame: Up to 5 years
Overall survival (OS)
Kaplan-Meier curves will be used to describe OS.
Time frame: From registration until death or last known follow-up, assessed up to 5 years
Failure-free survival (FFS)
Kaplan-Meier curves will be used to describe FFS.
Time frame: Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years
Duration of response
Kaplan-Meier curves will be used to describe duration of response.
Time frame: Time between the initial documentation of response and subsequent failure (death, disease progression), assessed up to 5 years
Toxicity as assessed by NCI's Common Toxicity Criteria
The frequency of occurrence of various toxicities will be tabulated by the most severe occurrence experienced by each individual patient.
Time frame: Up to 5 years
Relationship between HER2 expression in tumor tissue and serum
A 95% confidence interval for this proportion will be estimated using the binomial distribution. The level of circulating HER2 receptor will be descriptively summarized with means, medians, quartiles, etc.
Time frame: Up to 5 years
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