A phase I/II study of Cisplatin, Amrubicin plus irradiation for Limited disease small cell lung cancer
- Conditions
- small cell lung cancer
- Registration Number
- JPRN-UMIN000005816
- Lead Sponsor
- agasaki Thoracic Oncology Group
- Brief Summary
Eight patients were enrolled at three dose levels. Two of two patients in 30 mg/m2 dose level experienced DLTs. The presentation of DLTs included grade4 neutropenia and leukopenia lasting more than four days. Evaluation of responses were 7 partial response and 1 progressive disease (response rate 87.5%). The MTD of amrubicin and cisplatin were determined as 30 mg/m2 and 60 mg/m2. A dose of 25 mg/m2 amrubicin and cisplatin 60 mg/m2 was recommended in this regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
(1)stage IA (2)accumulated cardiac effusion (3)accumulated pleural effusion (4)Patients with active severe infections (5)Women during pregnancy (6)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
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 Toxicity