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

Sponsor

Chonnam National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00826644

Collaborator

Chong Kun Dang Pharmaceutical (Industry)

147

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 1, 2009

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Belotecan plus Cisplatin	Drug: Belotecan Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks Other Names: 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

Arm

Intervention/Treatment

Experimental: Belotecan plus Cisplatin

Drug: Belotecan

Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks

Other Names:

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

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 [two years]

Secondary Outcome Measures

to assess the overall response duration [two years]
To assess the time to progression [two years]
to assess the overall survival [two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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