extended small cell lung cancer
Conditions
Interventions
Four cycles of Cicplatin(60mg/m2 day1)and Irinotecan(60mg/m2 day1, 8,15) followed by maintenance Irinotecan(CPT-11)(60mg/m2 day1, 8,15) until disease progression.
Sponsors
Division of Thoracic Oncology, National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pathologically diagnosed as small cell lung cancer 2)Diagnosed as extended small cell lung cancer based on chest CT, abdominal CT, bone scintigraphy or brain MRI at the onset of disease. 3)Age 20=<,70=> 4)ECOG PS0or1 5)Measurable or nonmeasrurable lesions 6)CR or PR is achieved after the prior chemotherapy of Cisplatin (60mg/m2) and Irinotecan(60mg/m2 day1,8,15) . 7)Administered at least 9 times Irinotecan in prior IP chemotherapy 8)Registered after irradiated PCI, in the case of brain metastasis was not found before the prior chemotherapy. PCI is not always required. 9)Registered after irradiated WBRT(3Gy/Fr total 30Gy) after the prior IP chemotherapy , in the case of brain metastasis was found before the prior chemotherapy. WBRT is required. 10)No history of chemotherapy for other than lung cancer, and radiotherapy or surgery for primary lung cancer. 11)Adequate organ function, evaluated within 14 days before enrollment as; 1.WBC >=3,000/mm3 and Neutrophil >=1,500/mm3 1.Hemoglobin >=9.0 g/dL 3.Platelets >=100,000/mm3 4.Total bilirubin <=2.0mg/mL 5.GOT(AST)<=100 IU/L 6.GPT(ALT)<=100 IU/L 7.Serum creatinine <=1.5 mg/dL 8.PaO2>=70mmHg or SpO2>=95% 9.Normal electrocardiogram 12)Passed 4 weeks and over, under 8 weeks, from the last day of the administration of the IP chemotherapy. 13)Expected to live over 3 months from the first day of the chemotherapy. 14)Written informed consent from the patients.
Exclusion criteria
Exclusion criteria: 1)Active multiple malignacy 2)Grave complications 3)Bacterial infectious or fungus infection 4)Diarrhea 5)Paresis of intestine or ileus 6)Interstitial pneumonia or pulmonary fibrosis on chest CT 7)Dose of Irinotecan in prior chemotherapy is >60 mg/m2 at fourth course 8)Uncontrolled diabetes 9)Grave heart disease 10)Psychological disease decided not to be registered to this study 11)Pregnant or lactating women 12)Gastroduodenal ulcer 13)Grave complications 14)Doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival progression-free survival response rate rate of adverse events | — |
Countries
Japan
Contacts
Public ContactShigeki Umemura
National Cancer Center Hospital East Division of Thoracic Oncology
Outcome results
None listed