Lung Cancer Clinical Trial

Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

Summary

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

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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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)
At least 6 months since prior radiotherapy
No concurrent palliative radiotherapy
At least 4 weeks since prior major surgery

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT00004883

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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Cancer and Leukemia Group B
Chicago Illinois, 60606, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT00004883

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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