Carcinoma, Small Cell
Conditions
Keywords
Small cell lung cancer, Camptothecin, Response rate
Brief 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
Interventions
DRUGBelotecan
Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks
DRUGEtoposide
Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks
DRUGCisplatin
Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks
Sponsors
Chong Kun Dang Pharmaceutical
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer | two years |
Secondary
| Measure | Time frame |
|---|---|
| to assess the overall response duration | two years |
| To assess the time to progression | two years |
| to assess the overall survival | two years |
Countries
South Korea
Outcome results
None listed