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

A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer

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

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