Status:
COMPLETED
A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.
Detailed Description
A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell inj.) or Topotecan in Patients with Relapsed Small Cell Lung Cancer
Eligibility Criteria
Inclusion
- At least 18 years of age
- Histological or cytological diagnosis of SCLC
- Limited disease (LD) or Extensive disease (ED) at time of study entry
- Recurrent or progressive SCLC ≥ 90 days of duration of response for firstline therapy
- Measurable disease defined by RECIST criteria
- ECOG Performance Status of 0, 1, or 2
- Life expectancy ≥ 3 months
- Adequate bone marrow, Renal, Hepatic reserve:
- absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/mm3 platelet count ≥ 100,000 cells/ mm3 hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 mm3 Alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤ 2.0 X ULN Alkaline Phosphatase (ALP) ≤ 2.0 X ULN Serum creatinine ≤ 1.5mg/dL or calculated creatinine clearance \> 60mL/min
- \- Signed a written informed consent
Exclusion
- Active infection
- Symptomatic brain lesion
- Any other type of cancer during the previous 5 years
- Severe concurrent diseases
- Prior anticancer therapy within 4 weeks before enroll
- Active pregnancy test and Pregnant or nursing women
- Participation in any investigational drug study within 28 days prior to study entry
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT01497873
Start Date
September 1 2010
End Date
March 1 2018
Last Update
December 27 2018
Active Locations (14)
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1
Chungbuk University Hospital
Daegu, South Korea
2
Keimyung University Dongsan Center
Daegu, South Korea
3
National Cancer Center
Goyang, South Korea, 410-769
4
Asan Medical Center
Seoul, South Korea