small cell lung cancer
Conditions
Interventions
Amrubicin monotherapy
Sponsors
Kitasato University School of Medicine Department of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)histological or cytological confirmation of SCLC; (2) confirmation of extensive disease based on results of chest X-ray, computed tomography (CT) of the chest and abdomen, and other procedures, including magnetic resonance imaging (MRI) of the head, bone scintiscan, and positron emission tomography (PET) or combined PET/CT; (3) age 75 years or older, or performance status (PS) of 2 or more according to the Eastern Cooperative Oncology Group (ECOG) scale; (4) adequate bone marrow, hepatic, and renal function; (5) written informed consent.
Exclusion criteria
Exclusion criteria: Patients were ineligible if they had serious infectious diseases or other severe complications (heart disease, pulmonary fibrosis/interstitial pneumonia, or uncontrollable diabetes); had massive pleural or pericardial effusion, or ascitic fluid; had symptomatic brain metastases; had active concurrent malignancies; were lactating or pregnant women or hoped to become pregnant; had a history of a drug allergy; or had other medical problems severe enough to prevent compliance with the protocol. Prior amrubicin chemotherapy was not allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Overall survival,Safety | — |
Countries
Japan
Contacts
Public ContactSatoshi Igawa
Kitasato University School of Medicine Department of Respiratory Medicine
Outcome results
None listed