Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

NCT ID: NCT00660504

Last Updated: 2014-07-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-08-31

Brief Summary

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This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Amrubicin Hydrochloride-Cisplatin combined chemotherapy

Group Type EXPERIMENTAL

Amrubicin Hydrochloride

Intervention Type DRUG

Amrubicin Hydrochloride combined with cisplatin

2

Etoposide-Cisplatin combined chemotherapy

Group Type ACTIVE_COMPARATOR

Etoposide-Cisplatin combined chemotherapy

Intervention Type DRUG

combined chemotherapy

Interventions

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Amrubicin Hydrochloride

Amrubicin Hydrochloride combined with cisplatin

Intervention Type DRUG

Etoposide-Cisplatin combined chemotherapy

combined chemotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically/cytologically proven small cell lung cancer
* Extensive disease
* No prior chemotherapy regimen
* Age 18 years or older
* ECOG performance status of 0-1

Exclusion Criteria

* Brain metastasis requiring treatment
* Treatment (Surgical or radiotherapy)of primary tumor
* Interstitial pneumonia or pulmonary fibrosis
* Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Science

Locations

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Fuzhou, Fujian, China

Site Status

Lanzhou, Gansu, China

Site Status

Guangzhou, Guangdong, China

Site Status

Changsha, Hunan, China

Site Status

Nanjing, Jiangsu, China

Site Status

Nanchang, Jiangxi, China

Site Status

Changchun, Jilin, China

Site Status

Dalian/Shenyang, Liaoning, China

Site Status

Shenyang, Liaoning, China

Site Status

Xian, Shanxi, China

Site Status

Chengdu, Sichuan, China

Site Status

Hangzhou, Zhejiang, China

Site Status

Beijing, , China

Site Status

Shanghai, , China

Site Status

Tianjin, , China

Site Status

Countries

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China

References

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Sun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6.

Reference Type DERIVED
PMID: 27061082 (View on PubMed)

Other Identifiers

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D0750018

Identifier Type: -

Identifier Source: secondary_id

D0750018

Identifier Type: -

Identifier Source: org_study_id

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