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Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient (COMBAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00826644
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : August 9, 2021
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
In-Jae, Oh, MD, Chonnam National University Hospital

Study Description
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Brief Summary:

Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.

Primary endpoints

  • to assess Response Rate

Secondary endpoints

  • to assess Overall response duration, Time to progression, Overall survival

Condition or disease Intervention/treatment Phase
Carcinoma, Small Cell Drug: Belotecan Drug: Etoposide Drug: Cisplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
Actual Study Start Date : January 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Belotecan plus Cisplatin Drug: Belotecan
Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks
Other Name: Camtobell

Drug: Cisplatin
Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks
Active Comparator: Etoposide plus Cisplatin Drug: Etoposide
Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks

Drug: Cisplatin
Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks


Outcome Measures
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Primary Outcome Measures :
  1. To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer [ Time Frame: two years ]

Secondary Outcome Measures :
  1. to assess the overall response duration [ Time Frame: two years ]
  2. To assess the time to progression [ Time Frame: two years ]
  3. to assess the overall survival [ Time Frame: two years ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG Performance status 0~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
  • Histologically or cytologically confirmed small cell lung cancer Patient without chemotherapy and radiotherapy
  • Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
  • Life expectancy of at least 3 months
  • Provision of written informed consent

Exclusion Criteria:

  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease
  • Serum bilirubin greater than 3 times the upper limit of reference range(ULRR)
  • Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of liver metastases)
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  • Pregnancy or breast-feeding women(women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
  • Evidence of brain metastasis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826644


Locations
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Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Korea, Republic of, 58128
Sponsors and Collaborators
Chonnam National University Hospital
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: In-Jae Oh, M.D.,Ph.D. Chonnam National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: In-Jae, Oh, MD, Assistant Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT00826644    
Other Study ID Numbers: CSCLC-0810
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by In-Jae, Oh, MD, Chonnam National University Hospital:
Small cell lung cancer
Camptothecin
Response rate
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Etoposide
Belotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors