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About
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
Full description
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.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Histologically confirmed stage IIIB or IV non-small cell lung cancer
No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy
Recurrent disease allowed
HER2 overexpression (2-3+)
At least 1 unidimensionally measurable lesion
At least 20 mm by conventional techniques
At least 10 mm by spiral CT scan
The following are not considered measurable:
No CNS metastases
Performance status - ECOG 0-2
Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Creatinine no greater than 1.5 times ULN
LVEF at least 45% (by echocardiogram or MUGA)
Not pregnant or nursing
Fertile patients must use effective contraception
HIV negative
No concurrent immunologic disease (e.g., autoimmune disease)
No history of allergy to murine products
No prior murine antibodies
No prior anthracyclines
No more than 1 prior chemotherapy regimen for lung cancer
At least 4 weeks since prior chemotherapy
No concurrent chemotherapy
No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic
No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)
At least 6 months since prior radiotherapy
No concurrent palliative radiotherapy
At least 4 weeks since prior major surgery
Primary purpose
Allocation
Interventional model
Masking
84 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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