Extensive disease small cell lung cancer
Conditions
Interventions
Cisplatin, Irinotecan, Ramucirumab
Sponsors
Shizuoka Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Cytologically or histologically confirmed SCLC . 2)Extensive disease 3)Aged 20 to 74 years old 4)ECOG Performance Status 0 or 1 5)No prior chemotherapy for SCLC; however,Patient with postoperative adjuvant chemotherapy history is eligible after more than 6 months. 6)Patients who have not received thoracic radiotherapy with radiation field within the thorax (the lung field and mediastinum). 7)Presence of measurable disease based on RECIST v.1.1; however, irradiated sites are excluded from measurable sites. 8)More than 14 days after the end of palliative radiotherapy in organs other than the chest (the same day of the week can be accepted). 9)Adequate organ functions 10)Life expectancy > 12 weeks. 11)Diarrhea and intestinal obstruction. 12)The patient has resolution to Grade <=1 by CTCAE v.4.0, of any toxic effects of prior anticancer therapy. 13)Women willing not to have children. For women of childbearing potential, serum or urine pregnancy test result during the 7 days prior to the registration must be negative. 14)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Symptomatic brain metastases 2)Major surgery within 28 days or have subcutaneous venous access device placement within 7 days, prior to registration 3)Active infection requiring systemic treatment 4)Body temperature >= 38 degrees Celsius 5)Congestive heart failure with NYHA Class II to IV, or symptomatic, uncontrollable arrhythmia 6)Cirrhosis with Child-Pugh classification B score or more severe, or hepatic encephalopathy history 7)Poorly controlled hypertension 8)Hemoptysis history, more than one-half teaspoonful, within 2 months 9)Vasculitis, grade 3 or above gastrointestinal hemorrhage, or clinically serious hemorrhage within 3 months 10)Gastrointestinal/bowel perforation, gastric ulcer, diverticulum, or fistula within 6 months 11)Poor wound healing or bone fracture within 28 days 12)Radiographic major blood vessel invasion or encasement by cancer 13)Radiographic intratumoral cavitation 14)Active double cancer 15)Myocardial infarction, unstable angina pectoris, cerebrovascular accident, or TIA within 6 months. Any events caused by arterial thromboembolism within 6 months. 16)Receiving long-term treatment of NSAIDS, antiplatelet drug within 7 days before the initial administration of the study drug. Aspirin less than 325mg per day is acceptable. 17)Participant of other clinical studies with other drugs, unapproved drugs and medical devices, or clinical studies that are considered scientifically or medically incompatible with this study 18)Serious hypersensitivity against platinum-based drugs or irinotecan 19)Continuous systemic administration of high-dose steroids equivalent to prednisolone >= 10 mg/day (oral or intravenous), immunosuppressants. Patients who are taking oral steroids equivalent to prednisolone <10 mg/day are acceptable. 20)Interstitial pneumonia, pulmonary fibrosis or severe emphysema 21)Positive HBs antigen 22)Pregnant or lactating women or women willing child-bearing 23)Psychiatric disease 24)The investigator judged ineligible with any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of dose-limiting toxicities | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, progression-free survival, overall survival, and incidence rate of adverse events | — |
Countries
Japan
Contacts
Public ContactHirotsugu Kenmotsu
Shizuoka Cancer Center Division of Thoracic Oncology
Outcome results
None listed