A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Phase 1
- Conditions
- small cell lung cancer
- Registration Number
- JPRN-C000000150
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Presence of pulmonary fibrosis with symptoms or apparent abnormality on chest X-rays, 2) Acute inflammation, infection 3) Massive pleural effusion or pericardial effusion 4) Uncontrollable diabetes mellitus 5) ileus, intestinal paralysis, diarrhea 6) Symptomatic brain metastasis 7) Severe heart disease 8) Pregnancy 9) Severe drug allergies 10) Prior radiotherapy to the chest or the pelvis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: to determine the maximum tolerated dose and the recommended dose for phase II study Phase II: to confirm the efficacy and toxicity of the combined therapy at the recommended dose
- Secondary Outcome Measures
Name Time Method