A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
Conditions
Small Cell Lung Cancer
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Conditions: Keywords
SCLC, belotecan, Ifosfamide
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Belotecan and Ifosfamide
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Status: Recruiting
Contact: Hee Kyung Ahn - +82-32-460-3229 - hkahn@gilhospital.com
Start Date
July 2011
Sponsors
Gachon University Gil Medical Center
Source
Gachon University Gil Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page