JPRN-UMIN000003540
Recruiting
Phase 2
Phase II study to investigate efficacy and safety of erlotinib in patients with advanced and recurrent NSCLC with poor performance status - Phase II study to investigate efficacy and safety of erlotinib in patients with advanced and recurrent NSCLC with poor performance status
Yamaguchi Thoracic Oncology Group(YTOG)0 sites20 target enrollmentApril 30, 2010
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yamaguchi Thoracic Oncology Group(YTOG)
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(1\) Patients with pulmonary disorders including idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia and drug\-induced pneumonia (2\) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome (3\)Patients with complication with infectious disease which requires intravenous injection of antibiotic or antimycotic agent (4\) Patients who have been treated with HER drugs (gefitinib, trastuzumab, lapatinib, cetuximab) (5\) Patients who are not able to take oral medication (6\) Patients with clinically significant ophthalmologic disorder (severe eye disorders including Sjogren's syndrome, keratoconjunctivitis sicca, keratitis) (7\) Pregnant or lactating women (8\) Brain metastasis with symptoms (9\) Active multiple cancer (10\) Diabetes patients with poor disease control (11\) Patients with clinically significant complications (including cardiac disorder with poor control, severe arrhythmia requires medication, persistent watery diarrhea) (12\) Patients who are considered ineligible based on decision of a responsible investigator
Outcomes
Primary Outcomes
Not specified
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