Clinical trial NCT01497873: A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Small Cell Lung Cancer
Belotecan
Topotecan
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Objectives Response Rate(ORR, %)
timeFrame: Up to 18weeks
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 7years
measure: Progression Free survival(PFS)
timeFrame: Up to 18weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Chungbuk University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Center
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Veterans Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon
country: Korea, Republic of
facility: St. Vincents Hospital
Study officials:
affiliation: National Cancer Center
name: Heung Tae Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea Seoul St. Marys Hospital
name: Jin Hyoung Kang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: Jin Young Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Dong-Wan Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Sang-We Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Yonsei Cancer Center
name: Hye Ryeon Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Jin Hyuk Choi, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: Ki Hyeong Lee, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincents Hospital
name: Ho Jung An, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee University Medical Hospital
name: Chi Hoon Maeng, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Jin-Soo Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Choung Ang University Hospital
name: Joung Soon Jang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul Veterans Hospital
name: Bong Seog Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA Bundang Medical Center
name: Joo-Hang Kim, .D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang JH, Lee KH, Kim DW, Kim SW, Kim HR, Kim JH, Choi JH, An HJ, Kim JS, Jang JS, Kim BS, Kim HT. A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer. Br J Cancer. 2021 Feb;124(4):713-720. doi: 10.1038/s41416-020-01055-5. Epub 2020 Nov 16.