A phase II trial of sequential treatment from cisplatin-etoposide therapy (PE) to irinotecan hydrochloride + amrubicin hydrochloride therapy with concomitant use of G-CSF nartograstim in patients with extensive-stage small cell lung cancer or advanced large cell neuroendocrine carcinoma (LCNEC)
- Conditions
- Extensive-stage small cell lung cancer and stage IIIB/IV large cell neuroendocrine carcinoma (LCNEC)
- Registration Number
- JPRN-UMIN000006497
- Lead Sponsor
- Department of Respiratory Medicine Kitasato University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 31
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Step 1: Tolerability Step 2: Response rate
- Secondary Outcome Measures
Name Time Method Antitumor effect, survival, and safety (type, frequency, and grade of side effects)