Back to resultsA Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Belotecan and Ifosfamide
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring SCLC, belotecan, Ifosfamide
Eligibility Criteria
Inclusion Criteria:
- histologically or cytologically confirmed extensive disease of Small cell lung cancer
- no prior chemotherapy or radiotherapy for lung
- measurable lesion for RECIST
- over 18 years
- ECOG 0~2
- expected life span more than 3 months
Exclusion Criteria:
- acute or active infection
- uncontrolled cerebral nerve symptoms or metastasis
- significant myocardial infarction or cardiac disease within 12 months
Sites / Locations
- Gachon University Gil Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Belotecan and Ifosfamide
Arm Description
Outcomes
Primary Outcome Measures
MTD (maximal tolerated dose)
Secondary Outcome Measures
DLT(dose-limiting toxicity)
Full Information
NCT ID
NCT01784107
First Posted
January 30, 2013
Last Updated
February 9, 2016
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01784107
Brief Title
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
Official Title
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
5. Study Description
Brief Summary
Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide.
Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
SCLC, belotecan, Ifosfamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Belotecan and Ifosfamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Belotecan and Ifosfamide
Primary Outcome Measure Information:
Title
MTD (maximal tolerated dose)
Time Frame
one year
Secondary Outcome Measure Information:
Title
DLT(dose-limiting toxicity)
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Response rate
Time Frame
one year
Title
PFS(Progression-Free-Survival)
Time Frame
one year
Title
Overall Survival
Time Frame
one year
Title
Number of participants with adverse events
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically or cytologically confirmed extensive disease of Small cell lung cancer
no prior chemotherapy or radiotherapy for lung
measurable lesion for RECIST
over 18 years
ECOG 0~2
expected life span more than 3 months
Exclusion Criteria:
acute or active infection
uncontrolled cerebral nerve symptoms or metastasis
significant myocardial infarction or cardiac disease within 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Kyung Ahn
Phone
+82-32-460-3229
Email
hkahn@gilhospital.com
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Kyung Ahn
Phone
+82-32-460-3229
Email
hkahn@gilhospital.com
12. IPD Sharing Statement
Learn more about this trial
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
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