Multicenter phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320)
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000010582
- Lead Sponsor
- Thoracic Oncology Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
1)interstitial pneumonia or pulmonary fibrosis detectable on CT 2)3)smoking within 1 year 4)active severe infections 5)massive pleural effusion, ascites pericardial effusion 6)radiation of primary region or measurable region 5)history of sevirevere drug allergy 6)clinically important opthalmic disorders 7)brain metastasis associated with central nervous symptoms(patients were ineligible if the symptoms were controlled by steroids) 8)active concomitant cancers 9)history of concomitant cancers within 5 years 10)history of bone marrow transplant or peripheral stem cell transplantation 11)constant diarrhea 12)with intestinal paralysis or ileus 13)current or previous(within the last 1 year) of GI perfomation 14)uncontrollable ulcer in digestive tract 15)uncontrolled diabetes 16)current or history of severe heart disease 17)severe psychological disease 18)pregnant or lactating women or those who declined contraception 19)patients who were judged to be not suitable for trial by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival,
- Secondary Outcome Measures
Name Time Method response rate, disease control rate, time to treatment failure, overall survival, safety