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

Study Overview
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Brief Summary
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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

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

Conditions
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Carcinoma, Small Cell

Intervention / Treatment
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* Drug: Belotecan
* Drug: Etoposide
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Belotecan plus Cisplatin<br> | Drug: Belotecan<br>* Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks<br>* Other names: Camtobell;Drug: Cisplatin<br>* Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks<br>|
| Active Comparator: Etoposide plus Cisplatin<br> | Drug: Etoposide<br>* Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks<br>Drug: Cisplatin<br>* Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess the overall response duration |  | two years | 
| To assess the time to progression |  | two years | 
| to assess the overall survival |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small cell lung cancer, Camptothecin, Response rate