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

Carcinoma, Small Cell Clinical Trial

— COMBAT  

Official title:

A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826644
• Other study ID #: CSCLC-0810
• Status: Completed
• Phase: Phase 3
• Start date: January 2009
• Est. completion date: February 2013

Study information

• Verified date: August 2021
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Belotecan
Belotecan : 0.5mg/?/day for Day 1 to 4, repeated every 3 weeks
• Etoposide
Etoposide 100mg/?/day for Day 1 to 3, repeated every 3 weeks
• Cisplatin
Cisplatin 60mg/?/day for Day 1, repeated every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun

Sponsors (2)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer		two years
Secondary	to assess the overall response duration		two years
Secondary	To assess the time to progression		two years
Secondary	to assess the overall survival		two years