Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Conditions
Carcinoma, Small Cell
Conditions: official terms
Carcinoma, Small Cell - Small Cell Lung Carcinoma
Conditions: Keywords
Small cell lung cancer, Camptothecin, Response rate
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Belotecan/Cisplatin Type: Drug
Name: Etoposide/Cisplatin Type: Drug
Overall Status
Recruiting
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
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
Location
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 - droij@chonnam.ac.kr
Start Date
January 2009
Completion Date
December 2012
Sponsors
Chonnam National University Hospital
Source
Chonnam National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page