NCT00826644
Completed
Phase 3
A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
ConditionsCarcinoma, Small Cell
Overview
- Phase
- Phase 3
- Intervention
- Belotecan
- Conditions
- Carcinoma, Small Cell
- Sponsor
- Chonnam National University Hospital
- Enrollment
- 147
- Locations
- 1
- Primary Endpoint
- To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 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
Investigators
In-Jae, Oh, MD
Assistant Professor
Chonnam National University Hospital
Eligibility 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
Arms & Interventions
Belotecan plus Cisplatin
Intervention: Belotecan
Belotecan plus Cisplatin
Intervention: Cisplatin
Etoposide plus Cisplatin
Intervention: Etoposide
Etoposide plus Cisplatin
Intervention: Cisplatin
Outcomes
Primary Outcomes
To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer
Time Frame: two years
Secondary Outcomes
- to assess the overall survival(two years)
- To assess the time to progression(two years)
- to assess the overall response duration(two years)
Study Sites (1)
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