Phase I/II study of Irinotecan and Erlotinib in patients for EGFR mutation negative previously treated non-small-cell lung cancer.
Phase 1
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000005181
- Lead Sponsor
- Osaka Univ. Hospital Respiratory Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Diagnosed mutation or heterozygosity of UGT1A1*6/*28. (2)Serious drug allergy. (3)Interstitial pneumonia documented obviously in chest X ray. (4)massive pleural or pericardial effusion ,or ascites. (5)active severe infections. (6)Active synchronous malignancies. (7)Pregnant or beeast-feeding woman or patient who doesn't agree to contraception. (8)Serious psychological disease. (9)brain metastasis. (10)Clinically significant heart disease (myocardial infarction within 12 months, etc.). (11)Uncontrolled diabetes mellitus. (12)Watery diarrhea. (13)Ileus or bowel obstruction. (14)bleeding that requires medication or transfusion. (15)Clinically significant complication. (16)Investigator's judgement.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method