A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer
Both
Small Cell Lung Cancer
Trial Information
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MTD (maximal tolerated dose)
Outcome Time Frame:
one year
Safety Issue:
Yes
Authority:
South Korea: Institutional Review Board
Study ID:
2011-GIRBA-2550
NCT ID:
NCT01784107
Start Date:
July 2011
Completion Date:
Related Keywords:
- Small Cell Lung Cancer
- SCLC
- belotecan
- Ifosfamide
- Lung Neoplasms
- Small Cell Lung Carcinoma
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