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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Chonnam National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
In-Jae, Oh, MD, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT00826644
First received: January 21, 2009
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Carcinoma, Small Cell
Drug: Belotecan/Cisplatin
Drug: Etoposide/Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to assess the overall response duration [ Time Frame: two years ] [ Designated as safety issue: No ]
  • To assess the time to progression [ Time Frame: two years ] [ Designated as safety issue: No ]
  • to assess the overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belotecan Drug: Belotecan/Cisplatin
Belotecan : 0.5mg/㎡/day for Day 1 to 4, Cisplatin : 60mg/㎡/day for Day 1.
Active Comparator: Etoposide Drug: Etoposide/Cisplatin
Etoposide : 100mg/㎡/day for Day 1 to 3, Cisplatin : 60mg/㎡/day for Day 1. Repeat next cycle at Day 22.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826644

Contacts
Contact: In-Jae Oh, M.D.,Ph.D. 82-61-379-7617 droij@chonnam.ac.kr
Contact: Kyu-Sik Kim, M.D.,Ph.D. 82-61-379-7615 cyberkks@chonnam.ac.kr

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun-gun, Jeonnam, Korea, Republic of
Contact: In-Jae Oh, M.D.,Ph.D.    82-61-379-7617    droij@chonnam.ac.kr   
Sponsors and Collaborators
Chonnam National University Hospital
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: In-Jae Oh, M.D.,Ph.D. Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: In-Jae, Oh, MD, Assistant Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT00826644     History of Changes
Other Study ID Numbers: CSCLC-0810
Study First Received: January 21, 2009
Last Updated: January 9, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chonnam National University Hospital:
Small cell lung cancer
Camptothecin
Response rate

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Belotecan
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014