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Study to Assess of Belotecan or Topotecan on Daily Schedule in Relapsed Small Cell Lung Cancer (SCLC) Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01497873
First received: April 20, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: Topotecan
Drug: Belotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Objectives Response Rate [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]
  • Progression Free survival [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: September 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 disease progression
Other Name: 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 disease progression
Other Name: Hycamtin Injection

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 first-line 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/μL
    • platelet count ≥ 100,000 cells/μL
    • hemoglobin ≥ 9 g/dL
    • Total bilirubin ≤ 1.5 X ULN
    • 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 except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497873

Contacts
Contact: Heungtai Kim, PhD, Dr 82-31-920-0408

Locations
Korea, Republic of
Chungbuk University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Ki Hyung Lee    82-43-269-6015      
Keimyung University Dongsan Center Recruiting
Daegu, Korea, Republic of
Contact: Hong Suk Song    82-53-250-7436      
National Cancer Center Recruiting
Goyang, Korea, Republic of, 410-769
Contact: Heung Tai Kim    82-31-920-1622      
Principal Investigator: Heung Tai Kim         
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jin Soo Kim    82-2-870-3202      
Chung-Ang University hospital Recruiting
Seoul, Korea, Republic of
Contact: Joung Soon Jang    82-2-6299-1427      
Kyung Hee University Medical Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jae Heon Jeong    82-2-958-8723      
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong Wan Kim    82-2-2072-2995      
Seoul St. Marys Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jin Hyoung Kang    82-2-2258-2680      
Seoul Veterans Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bong Seog Kim    82-2-2225-1319      
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Joo Hang Kim         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sang We Kim    82-2-3010-3215      
St. Vincents Hospital Recruiting
Suwon, Korea, Republic of
Contact: Hoon Kyo Kim    82-2-540-7935      
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Jin Hyuk Choi    82-31-219-4920      
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 Seoul St. Marys Hospital
Principal Investigator: Hong Suk Song, M.D., Ph.D 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: Joo Hang Kim, M.D., Ph.D Severance Hospital
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
Principal Investigator: Hoon Kyo Kim, M.D., Ph.D St. Vincents Hospital
Principal Investigator: Jae Heon Jeong, M.D., Ph.D Kyung Hee University Medical Hospital
Principal Investigator: Jin Soo Kim, M.D., Ph.D Seoul national University 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
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01497873     History of Changes
Other Study ID Numbers: 11SCLC09I
Study First Received: April 20, 2011
Last Updated: October 6, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Small Cell Lung Cancer
Belotecan
Topotecan

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Belotecan
Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014