Lung Squamous Cell Carcinoma
Conditions
Interventions
Amrubicin is administered intravenously at a dose of 35 mg/m2/day on days 1-3 every 3 weeks.
Sponsors
First Department of Surgery, Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven squamous cell lung cancer. 2) Stage III/IV without indication for curative resection and post-operative recurrent disease 3) Patients who have previously treated with plutimun doublet chemotherapy. 4) Target lesion is measurable(RECISTver1.1) 5) More than 28 days after last chemotherapy and more than 28 days rest period after radiation 6) ECOG performance status 0-1 7) Patients aged 20-74 years 8) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment: Leukocyte counts, 4,000/mm3 to 12,000/mm3. Neutrophil counts, 2,000/mm3 or over. Platelets, 100,000/mm3 or over. Hemoglobin, 9.5g/dL or over AST and ALT, x 2.5 of upper limit of normal (ULN) or less. Serum bilirubin, 1.5mg/dl or less. Serum creatinin, x 1.5 of ULN or less. Arterial oxygen partial pressure 60 Torr or above. Adequate heart function by ECG. LVEF, 60% or over. 9) Written informed consent from the patients
Exclusion criteria
Exclusion criteria: 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 with cardiac infarction or unstable angina within 12 months. Patients need to recieve medications for their bad heart function. 10) Patients who have previously treated with a cumulative daunorubicin dose > 25 mg/kg, doxorubicin >500 mg/m2, epirubicin >900mg/m2, pirarubicin > 950mg/m2. 11) a serious or uncontrolled concomitant systematic disorder (active gastric or duodenal ulcer, uncontrolled diabetes mellitus, or cerebral infarction within 6 months.) 12) Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Progression-free survival (PFS) Response Rate (RR) Toxicity profiles | — |
Countries
Japan
Outcome results
None listed