Phase II study of amrubicin monotherapy for treating elderly and poor-risk patients with small-cell lung cancer.
Phase 2
- Conditions
- small cell lung cancer
- Registration Number
- JPRN-UMIN000011055
- Lead Sponsor
- Kitasato University School of Medicine Department of Respiratory Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression free survival, Overall survival,Safety