A combination phase I study of topotecan with cisplatin for elderly small cell lung cancer

UMIN ID: C000000143

Registered date:08/09/2005

Basic Information

• Health condition(s) or Problem(s) studied: small cell lung cancer
• Date of first enrollment: 2004/03/01
• Target sample size: 28
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Topotecan: 0.6, 0.8, 1.0, 1.2 mg/m2, day 1-3, every 3 weeks Cisplatin: 25 mg/m2, day 1-3, every 3 weeks

Outcome(s)

• Primary Outcome: Decision of the recommended dose of cisplatin and topotecan
• Secondary Outcome: Determination of dose limited toxicity and response and safety of the combination of topotecan and cisplatin

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Severe infection and complication (hemorrhage and heart disease etc.) 2)Intestinal pneumonia or lung fibrosis 3)Symptomatic brain metastasis 4)History of active other malignancy 5)History of severe drug allergic reaction 6)Pregnant women or women willing child-bearing 7)Men willing to have children 8)Uncontrolled diabetes 9)Uncontrolled pleural, cardiac, or abdominal effusion 10)Inadequate condition diagnosed by primary physician

Related Information

• Primary Sponsor: Department of Medical Oncology, Kinki University School of Medicine
• Source(s) of Monetary Support: Department of Medical Oncology, Kinki University School of Medicine