NIPH Clinical Trials Search

UMIN ID: C000000143

Registered date:08/09/2005

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

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedsmall cell lung cancer
Date of first enrollment2004/03/01
Target sample size28
Countries of recruitmentJapan
Study typeInterventional
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


Primary OutcomeDecision of the recommended dose of cisplatin and topotecan
Secondary OutcomeDetermination of dose limited toxicity and response and safety of the combination of topotecan and cisplatin

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1)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


public contact
Address 377-2 Ohno-higashi, Osaka-Sayama, Japan
Telephone 072-366-0221
Affiliation Kinki University School of Medicine Department of Medical Oncology
scientific contact
Name Kenji Tamura MD
Address 1248-1, Otoda, Ikoma, Nara, 630-0293, Japan Japan
Telephone 0743-77-0880
Affiliation Kinki University School of Medicine, Nara Hospital Department of Medical Oncology