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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chonnam National University Hospital
• Collaborator: Chong Kun Dang Pharmaceutical
• Treatments: Belotecan; Camptothecin; Cisplatin; Etoposide; Etoposide phosphate

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