A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Recurrent Non-small Cell Lung Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Response rate (complete response [CR] and partial response [PR])
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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
Detailed 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.
Investigators
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:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Response rate (complete response [CR] and partial response [PR])
Time Frame: Up to 5 years
Secondary Outcomes
- Overall survival (OS)(From registration until death or last known follow-up, assessed up to 5 years)
- Failure-free survival (FFS)(Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years)
- Duration of response(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(Up to 5 years)
- Relationship between HER2 expression in tumor tissue and serum(Up to 5 years)