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

December 25, 2018 updated by: Chong Kun Dang Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Chungbuk University Hospital
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Center
      • Goyang, Korea, Republic of, 410-769
        • National Cancer Center
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Boramae Medical Center
      • Seoul, Korea, Republic of
        • Seoul Veterans Hospital
      • Seoul, Korea, Republic of
        • CHA Bundang Medical Center
      • Seoul, Korea, Republic of
        • Kyung Hee University Medical Hospital
      • Seoul, Korea, Republic of
        • Seoul St. Marys Hospital
      • Seoul, Korea, Republic of
        • Yonsei Cancer Center
      • Suwon, Korea, Republic of
        • Ajou University Hospital
      • Suwon, Korea, Republic of
        • St. Vincents Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belotecan
Camtobell Injection
Drug: Belotecan
0.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
Other Names:
  • Camtobell Injection
Active Comparator: Topotecan
Hycamtin Injection
Drug: Topotecan
1.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
Other Names:
  • Hycamtin Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objectives Response Rate(ORR, %)
Time Frame: 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
Up to 18weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival(OS)
Time Frame: 7years
Defined as the time from the randomization to the time of death.
7years
Progression Free survival(PFS)
Time Frame: 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
Up to 18weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Heung Tae Kim, M.D., Ph.D, National Cancer Center
  • Principal Investigator: Jin Hyoung Kang, M.D., Ph.D, The Catholic University of Korea Seoul St. Marys Hospital
  • Principal Investigator: Jin Young Kim, M.D., Ph.D, Keimyung University Dongsan Medical Center
  • Principal Investigator: Dong-Wan Kim, M.D., Ph.D, Seoul National University Hospital
  • Principal Investigator: Sang-We Kim, M.D., Ph.D, Asan Medical Center
  • Principal Investigator: Hye Ryeon Kim, M.D., Ph.D, Yonsei Cancer Center
  • Principal Investigator: Jin Hyuk Choi, M.D., Ph.D, Ajou University School of Medicine
  • Principal Investigator: Ki Hyeong Lee, M.D., Ph.D, Chungbuk National University Hospital
  • Principal Investigator: Ho Jung An, M.D., Ph.D, St. Vincents Hospital
  • Principal Investigator: Chi Hoon Maeng, M.D., Ph.D, Kyung Hee University Medical Hospital
  • Principal Investigator: Jin-Soo Kim, M.D., Ph.D, SMG-SNU Boramae Medical Center
  • Principal Investigator: Joung Soon Jang, M.D., Ph.D, Choung Ang University Hospital
  • Principal Investigator: Bong Seog Kim, M.D., Ph.D, Seoul Veterans Hospital
  • Principal Investigator: Joo-Hang Kim, .D., Ph.D, CHA Bundang Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2010

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Actual)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 25, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11SCLC09I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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