phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.

UMIN ID: C000000113

Registered date:05/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: extensive disease small-cell lung cancer
• Date of first enrollment: 2004/09/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): single-arm phse II study. Patients receive irinotecan 60 mg/m2 intravenously on day 1 and 8 plus cisplatin 60 mg/m2 intravenously on day 1 every three weeks for three cycle, then amrubicin 40 mg/m2 intravenously on day 1 to 3 every three weeks for three cycle.

Outcome(s)

• Primary Outcome: Primary endpoint: response rate. Secondary endpoints: overall survival, time to progression, and toxicity.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Include criteria: 1) small-cell lung cancer; 2) extensive disease; 3) Eastern Cooperative Oncology Group performance status of 0 or 1; 4) age of 20 to 70 years; 5) no prior chemotherapy; 6) neither palliative radiation nor surgery within 14 days; 7) measurable lesions; 8) a life expectancy of at least two months; 9) adequate organ fanctions; and 10) written informed consent.
• Exclude criteria: 1) symptomatic brain metastases; 2) pleural or pericardial effusion requiring drainage; 3) interstitial pneumonitis or pulmonary fibrosis; 4) active infection; 5) watery diarrhea, paralysis of the intestine, or ileus; 6) active gastric or duodenal ulcer; 7) continuous administration of steroids or non-steroidal anti-inflammatory drugs; 8) uncontrolled diabetes mellitus or angina pectoris; 9) active concomitant malignancies; 10) a history of serious drug allergy; 11) pregnancy or lactation; and 12) unsuitable for entry to the study, decided by a medical oncologist.

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None