A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer
- Registration Number
- NCT01497873
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topotecan Topotecan Hycamtin Injection Belotecan Belotecan Camtobell Injection
- Primary Outcome Measures
Name Time Method Objectives Response Rate(ORR, %) Up to 18weeks The response rate was defined as the test subject who had a complete response (CR) or a partial response (PR) as determined by the 'tumor response evaluation' criteria specified in the research protocol
- Secondary Outcome Measures
Name Time Method Overall Survival(OS) 7years Defined as the time from the randomization to the time of death.
Progression Free survival(PFS) Up to 18weeks Defined as the elapsed time from the time of randomization to the time of confirmation of progression or the time of death
Trial Locations
- Locations (14)
National Cancer Center
🇰🇷Goyang, Korea, Republic of
Chungbuk University Hospital
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Center
🇰🇷Daegu, Korea, Republic of
Chung-Ang University hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Marys Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Medical Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Veterans Hospital
🇰🇷Seoul, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
St. Vincents Hospital
🇰🇷Suwon, Korea, Republic of
Yonsei Cancer Center
🇰🇷Seoul, Korea, Republic of