A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497873
• Other study ID #: 11SCLC09I
• Status: Completed
• Phase: Phase 2
• Start date: September 2010
• Est. completion date: March 2018

Study information

• Verified date: December 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Topotecan
1.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
• Belotecan
0.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk University Hospital	Daegu
Korea, Republic of	Keimyung University Dongsan Center	Daegu
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	CHA Bundang Medical Center	Seoul
Korea, Republic of	Chung-Ang University hospital	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 St. Marys Hospital	Seoul
Korea, Republic of	Seoul Veterans Hospital	Seoul
Korea, Republic of	Yonsei Cancer Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	St. Vincents Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objectives Response Rate(ORR, %)	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	Up to 18weeks
Secondary	Overall Survival(OS)	Defined as the time from the randomization to the time of death.	7years
Secondary	Progression Free survival(PFS)	Defined as the elapsed time from the time of randomization to the time of confirmation of progression or the time of death	Up to 18weeks