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

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Small Cell Lung Cancer

Treatments: Drug: Belotecan and Ifosfamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01784107

2011-GIRBA-2550

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Belotecan and Ifosfamide

Experimental group

Treatment:

Drug: Belotecan and Ifosfamide