Clinical trial NCT00826644: Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Official title: A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Small Cell
Keywords: Small cell lung cancer
Camptothecin
Response rate
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Chong Kun Dang Pharmaceutical
First posted: 2009-01-22
Enrollment: 147
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer
timeFrame: two years
Secondary outcomes:
measure: to assess the overall response duration
timeFrame: two years
measure: To assess the time to progression
timeFrame: two years
measure: to assess the overall survival
timeFrame: two years
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: In-Jae Oh, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh IJ, Kim KS, Park CK, Kim YC, Lee KH, Jeong JH, Kim SY, Lee JE, Shin KC, Jang TW, Lee HK, Lee KY, Lee SY. Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial. BMC Cancer. 2016 Aug 26;16(1):690. doi: 10.1186/s12885-016-2741-z.