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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01784107

Enrollment

Registered

2013-02-05

Start date

2011-07-31

Completion date

Unknown

Last updated

2016-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

SCLC, belotecan, Ifosfamide

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.

Interventions

DRUGBelotecan and Ifosfamide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
MTD (maximal tolerated dose)	one year

Secondary

Measure	Time frame
DLT(dose-limiting toxicity)	one year

Other

Measure	Time frame
Response rate	one year
PFS(Progression-Free-Survival)	one year
Overall Survival	one year
Number of participants with adverse events	one year

Countries

South Korea

Contacts

Primary ContactHee Kyung Ahn

hkahn@gilhospital.com+82-32-460-3229

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026