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

NCT ID: NCT01784107

Last Updated: 2016-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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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

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belotecan and Ifosfamide

Group Type EXPERIMENTAL

Belotecan and Ifosfamide

Intervention Type DRUG

Interventions

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Belotecan and Ifosfamide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eun Kyung Cho

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gachon University Gil Medical Center

Incheon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee Kyung Ahn

Role: CONTACT

+82-32-460-3229

Facility Contacts

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Hee Kyung Ahn

Role: primary

+82-32-460-3229

Other Identifiers

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2011-GIRBA-2550

Identifier Type: -

Identifier Source: org_study_id

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