Status:
COMPLETED
Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Lead Sponsor:
Chonnam National University Hospital
Collaborating Sponsors:
Chong Kun Dang Pharmaceutical
Conditions:
Carcinoma, Small Cell
Eligibility:
All Genders
19-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00826644
Start Date
January 1 2009
End Date
February 1 2013
Last Update
August 9 2021
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun, South Korea, 58128