Small Cell Lung Cancer
Conditions
Keywords
Small Cell Lung Cancer, Belotecan, Topotecan
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
Interventions
DRUGTopotecan
1.5 mg/m\^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
DRUGBelotecan
0.5 mg/m\^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed