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

G

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)

45 participants in 1 patient group

Belotecan and Ifosfamide
Experimental group
Treatment:
Drug: Belotecan and Ifosfamide

Trial contacts and locations

1

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Central trial contact

Hee Kyung Ahn

Data sourced from clinicaltrials.gov

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