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Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer

NCT ID: NCT00754858

Last Updated: 2014-12-02

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-06-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.

Detailed Description

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OBJECTIVES:

Primary

* To assess the antitumor efficacy, in terms of objective response rate, of belotecan hydrochloride and cisplatin in patients with previously untreated extensive-stage small cell lung cancer.

Secondary

* To assess additional evidence of antitumor activity as measured by overall and progression-free survival of these patients.
* To determine the safety and tolerability of this drug combination in these patients.

OUTLINE: Patients receive cisplatin IV on day 1 and belotecan hydrochloride IV on days 2-4.Treatment continues in the absence of disease progression or unacceptable toxicity.

Conditions

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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 Cisplatin

belotecan 0.5 mg/m2 and Cisplatin 60mg/m2

Group Type EXPERIMENTAL

belotecan hydrochloride

Intervention Type DRUG

cisplatin

Intervention Type DRUG

Interventions

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belotecan hydrochloride

Intervention Type DRUG

cisplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy
* No other concurrent chemotherapy, radiotherapy, or immunotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joo-Hang Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Yonsei Cancer Center at Yonsei University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YONSEI-4-2008-0127

Identifier Type: -

Identifier Source: secondary_id

CKDPC-YONSEI-4-2008-0127

Identifier Type: -

Identifier Source: secondary_id

YONSEI-07-YUHS-02

Identifier Type: -

Identifier Source: secondary_id

CDR0000614308

Identifier Type: -

Identifier Source: org_study_id