drugset / Trial / NCT00826644
Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Phase 3
Completed
147 enrolled
Chonnam National University Hospital
Chong Kun Dang Pharmaceutical · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belotecan | Small molecule | 0.5 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | — |
| Background | Cisplatin | Other / unclassified | 60 mg/m2 | — |