Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Carcinoma, Small Cell
Conditions: official terms
Carcinoma, Small Cell - Small Cell Lung Carcinoma
Conditions: Keywords
Small cell lung cancer, Camptothecin, Response rate
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Belotecan/Cisplatin Type: Drug
Name: Etoposide/Cisplatin Type: Drug
Overall Status
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 19 Years
Gender: Both
Criteria: Inclusion Criteria:

- ECOG Performance status 0~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)

- Histologically or cytologically confirmed small cell lung cancer Patient without chemotherapy and radiotherapy

- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site

- Life expectancy of at least 3 months

- Provision of written informed consent

Exclusion Criteria:

- As judged by the investigator, any evidence of severe or uncontrolled systemic disease

- Serum bilirubin greater than 3 times the upper limit of reference range(ULRR)

- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of liver metastases)

- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

- Pregnancy or breast-feeding women(women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy

- Evidence of brain metastasis
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonnam, Korea, Republic of
Status: Recruiting
Contact: In-Jae Oh, M.D.,Ph.D. - 82-61-379-7617 -
Start Date
January 2009
Completion Date
December 2012
Chonnam National University Hospital
Chonnam National University Hospital
Record processing date processed this data on July 28, 2015 page