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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT01497873
Collaborator
(none)
164
Enrollment
14
Locations
2
Arms
90
Actual Duration (Months)
11.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Overall Survival(OS) [7years]

      Defined as the time from the randomization to the time of death.

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chungbuk University Hospital Daegu Korea, Republic of
    2 Keimyung University Dongsan Center Daegu Korea, Republic of
    3 National Cancer Center Goyang Korea, Republic of 410-769
    4 Asan Medical Center Seoul Korea, Republic of
    5 CHA Bundang Medical Center Seoul Korea, Republic of
    6 Chung-Ang University hospital Seoul Korea, Republic of
    7 Kyung Hee University Medical Hospital Seoul Korea, Republic of
    8 Seoul National University Boramae Medical Center Seoul Korea, Republic of
    9 Seoul National University Hospital Seoul Korea, Republic of
    10 Seoul St. Marys Hospital Seoul Korea, Republic of
    11 Seoul Veterans Hospital Seoul Korea, Republic of
    12 Yonsei Cancer Center Seoul Korea, Republic of
    13 Ajou University Hospital Suwon Korea, Republic of
    14 St. Vincents Hospital Suwon Korea, Republic of

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT01497873
    Other Study ID Numbers:
    • 11SCLC09I
    First Posted:
    Dec 23, 2011
    Last Update Posted:
    Dec 27, 2018
    Last Verified:
    Dec 1, 2018
    Keywords provided by Chong Kun Dang Pharmaceutical
    Small Cell Lung Cancer
    Belotecan
    Topotecan
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Topotecan
    Belotecan

    Study Results

    No Results Posted as of Dec 27, 2018