Trial record 6 of 60 for:
"Carcinoma, Small Cell"
Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient (COMBAT)
This study is currently recruiting participants.
Verified January 2012 by Chonnam National University Hospital
Sponsor:
Chonnam National University Hospital
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
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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, Small Cell Carcinoma Lung Neoplasms Small Cell Lung Carcinoma 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 May 23, 2013