Extensive-stage small cell lung cancer and stage IIIB/IV large cell neuroendocrine carcinoma (LCNEC)
Conditions
Interventions
PE therapy: CDDP 80 mg/m2 on day 1 VP-16 100 mg/m2 on days 1-3 Three to four week treatment constitutes one course. CAN therapy: CPT-11 60 mg/m2 on days 1 and 8 AMR 35 mg/m2 on days 1-3
Sponsors
Department of Respiratory Medicine Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Confirmed small cell lung cancer and/or large cell neuroendocrine carcinoma (LCNEC) based on histological or cytological examination 2) Curative radiation therapy-naive extensive disease or stage IIIB/IV large cell neuroendocrine carcinoma (LCNEC) 3) No prior chemotherapy; however, treatment with biological response modifier (BRM) for pleural effusion management allowed if performed 14 days or more prior to enrollment. No prior radiotherapy and/or surgical treatment for the primary lesion of lung carcinoma; however, radiotherapy for other than primary lesions, thorax, and ilium allowed if performed 28 days or more prior to enrollment. 4) Age 75 years or younger at enrollment 5) Expected survival <= 8 weeks 6) ECOG performance status (PS) 0-2 7) No significant injury to key organs including bone marrow, heart, lung, liver, and kidney, etc., with laboratory values meeting all of the following: 1. White blood cell count <= 4,000/mm3 and >= 12,000 mm3 2. Platelet count <= 100,000/mm3 3. Hemoglobin <= 9.0 g/dL 4. AST (GOT) and ALT (GPT) >= 100 IU/L; however, up to 300 IU/L allowed in cases of liver metastasis. 5. Total bilirubin >= 2.0 mg/dL 6. Serum creatinine >= 1.5 mg/dL 7. Creatinine clearance <= 60 ml/min 8. PaO2 <= 60 torr 9. No abnormalities which require treatment with electrocardiogram 8) Sufficient explanation about the contents of the trial, followed by written informed consent by the participant in person prior to enrollment
Exclusion criteria
Exclusion criteria: 1) Superior vena cava syndrome 2) History of severe drug allergy 3) Large pleural effusion, ascites, and/or cardiac effusion 4) Clinically relevant infectious disease 5) Diarrhea (watery diarrhea) 6) Intestinal paralysis and/or ileus 7) Obvious interstitial pneumonia and/or pulmonary fibrosis based on chest X-ray 8) Brain metastasis with any symptoms; however, asymptomatic patients may be enrolled if symptoms are resolved after radiotherapy, not steroid therapy. 9) Simultaneously active double cancer*1 10) Uncontrollable diabetic disease 11) Clinically relevant cardiac diseases*2 12) Patients judged to be difficult to participate in the trial due to a clinically relevant neuropsychiatric disorder, etc. 13) Pregnant or lactating women, or those who may become pregnant or who have no intention of contraception 14) Patients whose participation in the trial was judged to be inappropriate due to safety reasons by investigators, etc. *1Double cancer comprises simultaneous double cancer and metachronous double cancer with a disease-free interval of 5 years or shorter. However, active double cancer does not include in-situ carcinoma or intramucosal carcinoma judged to be recovered by local treatment. *2These include congestive cardiac failure, symptomatic coronary artery disease, uncontrollable arrhythmia, and myocardial infarction occurring within preceding 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step 1: Tolerability Step 2: Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor effect, survival, and safety (type, frequency, and grade of side effects) | — |
Countries
Japan
Contacts
Public ContactSakiko Ootani
Kitasato University School of Medicine Department of Respiratory Medicine
Outcome results
None listed