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Keep this study
Lead
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed stage IIIB or IV non-small cell lung cancer
* Supraclavicular node involvement allowed
* Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative)
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:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Abdominal masses not confirmed and followed by imaging
* Cystic lesions
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)
