small cell lung cancer
Conditions
Interventions
The Amrubicine is administered on day 1-3, and the Irinotecan is administered on day 1 and 8 every three weeks.
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histological or cytological confirmation of SCLC 2) Extended disease or Limited disease with malignant effusion 3) Patients previously untreated with chemotherapy 4) At least 2 Months of Life expectancy 5) ECOG Performance Status (PS) 0-1 6) The presence of measurable region 7) Adequate organ function 8) 20 years or older to 70 years 9) Written informed consent
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed