A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer

Phase 1

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Belotecan and Ifosfamide

• Registration Number: NCT01784107
• Lead Sponsor: Gachon University Gil Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-02-03
• Study First Posted: 2013-02-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10
• Primary Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Belotecan and Ifosfamide	Belotecan and Ifosfamide	-

Primary Outcome Measures

Name	Time	Method
MTD (maximal tolerated dose)	one year

Secondary Outcome Measures

Name	Time	Method
DLT(dose-limiting toxicity)	one year

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of