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

Chonnam National University

Status and phase

Completed

Phase 3

Conditions

Carcinoma, Small Cell

Treatments

Drug: Etoposide

Drug: Cisplatin

Drug: Belotecan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00826644

CSCLC-0810

Details and patient eligibility

About

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

Enrollment

147 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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