Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
- Conditions
- Recurrent squamous cell lung cancer
- Registration Number
- JPRN-UMIN000006270
- Lead Sponsor
- Kansai Medical University Hirakata Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Not provided
1)Uncontrolled infection or Serious medical complications 2)Massive pleural effusion or ascites after drainage and controrable pleural effusion for 2 weeks accept controrable pleural effusion with OK-432 3)current or previous treated brain metastasis 4)severe cardiac disease 5)uncontrolled diabetes mellitus 6)receiving anticoagulant drug(except Aspirin under 325mg/day) 7)uncontrolled hypertension 8)current or previous (within the last 1 year) history of GI perforation 9)interstitial pneumonia or lung fibrosis evident on CT 10)history of drug induced interstitial pneumonia 11)patient who has been scheduling operation for examination period 12)treatment history of Amurubicin 13)severe drug allergy 14)active concomitant malignancy 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 Overall survival Progression Free Survival Adverse events