Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer
- Conditions
- Squamous Cell Lung Cancer
- Registration Number
- JPRN-UMIN000004235
- Lead Sponsor
- Society for the study of previously treated squamous cell lung cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Patients who have previously treated with chemotherapy containing amrubicin. 2) Patients with symptomatic brain metastasis. 3) Patients with massive uncontrolled pleural or pericardial effusion ,or ascites. 4) Patients with active severe infections 5) Patients with double cancer within 5 years. 6) Patients with active interstitial pneumonia recognized by chest X-ray. 7) Patients with serious drug allergic reactions. 8) Patients with active concomitant pregnancy. 9) Patients can not prevent a pregnancy. 10) Patients with cardiac infarction or unstable angina within 12 months. Patients need to recieve medications for their bad heart function. 11) Patients who have previously treated with a cumulative daunorubicin dose > 25 mg/kg, doxorubicin >500 mg/m2, epirubicin >900mg/m2, pirarubicin > 950mg/m2. 12) a serious or uncontrolled concomitant systematic disorder (active gastric or duodenal ulcer, uncontrolled diabetes mellitus, or cerebral infarction within 6 months.) 13) Conditon requiring chronic systematic administration of corticosteroids. 14) Inappropriate patients for this study judged by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Control Rate (DCR)
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Progression-free survival (PFS) Response Rate (RR) Toxicity profiles