drugset / Trial / NCT00826644

Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient

NCT00826644

RandomizedParallel-groupOpen-labelTreatment

Summary

Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer. Primary endpoints * to assess Response Rate Secondary endpoints * to assess Overall response duration, Time to progression, Overall survival

Timeline

Start
2009-01
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Belotecan Small molecule 0.5 mg/m2
Comparator Etoposide Small molecule 100 mg/m2
Background Cisplatin Other / unclassified 60 mg/m2

Indications