Recurrent squamous cell lung cancer
Conditions
Interventions
Amurubicin (35mg/m2,,i.v.)on Day1,2,3 every three weeks, patients who achieved disease control (response or stable disease) until disease progression, or without unfeasible and unacceptable toxisity
Sponsors
Kansai Medical University Hirakata Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically confirmed squamous cell lung cancer 2) patients with recurrent advanced squamous cell lung cancer after first line treatment 3) Age:at least 20 years of age 4) Eastern Cooperative Oncology Group performance status of 0,1 5) Measurable by RECIST(Ver4.0) criteria 6) Sufficient organ functions 7) written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Progression Free Survival Adverse events | — |
Countries
Japan
Contacts
Public ContactYoshitaro Torii
Kansai Medical University Hirakata Respiratory medicine
Outcome results
None listed