Study to Assess of Belotecan or Topotecan on Daily Schedule in Relapsed Small Cell Lung Cancer (SCLC) Patients
This study is currently recruiting participants.
Verified September 2012 by Chong Kun Dang Pharmaceutical
Sponsor:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01497873
First received: April 20, 2011
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: Topotecan Drug: Belotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase IIb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Relapsed Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Chong Kun Dang Pharmaceutical:
Primary Outcome Measures:
- Objectives Response Rate [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]
- Progression Free survival [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 176 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Belotecan |
Drug: Belotecan
0.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or disease progression
Other Name: Camtobell inj.
|
| Active Comparator: Topotecan |
Drug: Topotecan
1.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or disease progression
Other Name: Hycamtin inj.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least 18 years of age
- Histological or cytological diagnosis of SCLC
- Limited disease (LD) or Extensive disease (ED) at time of study entry
- Recurrent or progressive SCLC ≥ 90 days of duration of response for first-line therapy
- Measurable disease defined by RECIST criteria
- ECOG Performance Status of 0, 1, or 2
- Life expectancy > 3 months
Adequate bone marrow, Renal, Hepatic reserve:
- absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/μL
- platelet count ≥ 100,000 cells/μL
- hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 X ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 X ULN
- Alkaline Phosphatase (ALP) ≤ 2.0 X ULN
- Serum creatinine < 1.5mg/dL or calculated creatinine clearance > 60mL/min
- Signed a written informed consent
Exclusion Criteria:
- Active infection
- Symptomatic brain lesion
- Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix Severe concurrent diseases
- Prior anticancer therapy within 4 weeks before enroll
- Active pregnancy test and Pregnant or nursing women
- Participation in any investigational drug study within 28 days prior to study entry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497873
Contacts
| Contact: Heungtai Kim, PhD, Dr | 82-31-920-0408 |
Locations
| Korea, Republic of | |
| Keimyung University Dongsan Center | Recruiting |
| Daegu, Korea, Republic of | |
| Contact: Hong Suk Song 82-53-250-7436 | |
| Chungbuk University Hospital | Recruiting |
| Daegu, Korea, Republic of | |
| Contact: Ki Hyung Lee 82-43-269-6015 | |
| National Cancer Center. | Recruiting |
| Goyang, Korea, Republic of, 410-769 | |
| Contact: Heung Tai Kim 82-31-920-1622 | |
| Principal Investigator: Heung Tai Kim | |
| Severance Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Joo Hang Kim | |
| Seoul St. Mary's Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Jin-Hyoung Kang 82-2-2258-2680 | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Dong Wan Kim 82-2-2072-2995 | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Sang We Kim 82-2-3010-3215 | |
| St. Vincent's Hospital | Recruiting |
| Suwon, Korea, Republic of | |
| Contact: Hoon Kyo Kim 82-2-540-7935 | |
| Ajou University Hospital | Recruiting |
| Suwon, Korea, Republic of | |
| Contact: Jin Hyuk Choi 82-31-219-4920 | |
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
More Information
No publications provided
| Responsible Party: | Chong Kun Dang Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT01497873 History of Changes |
| Other Study ID Numbers: | 11SCLC09I |
| Study First Received: | April 20, 2011 |
| Last Updated: | September 11, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Chong Kun Dang Pharmaceutical:
|
Small Cell Lung Cancer Belotecan Topotecan |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Topotecan Belotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013