Phase II study of erlotinib in advanced or recurrent EGFR mutation positive Non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion.
Phase 2
Recruiting
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000006518
- Lead Sponsor
- Kitasato university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1,Massive pericardial effusion or ascites 2,Severe drug allergy 3,Active infection 4,Continuous watery diarrhea 5,Intestinal paralysis or ileus 6,Interstitial pneumonia or lung fibrosis evident on CT 7,Symptomatic ophthalmologic disease 8,Current or previous (within the last 1 year) history of GI perforation 9,Serious non—healing ulcer 10,Symptomatic or steroid-requiring brain metastases 11,Active concomitant malignancy 12,Previous (within the last 5 years) concomitant malignancy 13,Uncontrolled diabetes 14,Severe cardiac disease 15,Severe psychological disease 16,Pregnant or lactating women or those who declined contraception 17,Those judged to be not suitable by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Disease control rate, Progression free survival, Overall survival, Adverse events, 4-weeks pleural effusion progression free survival rate, Pleural effusion progression free suvival