NCT00660504

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P25-P50 for phase_3 lung-cancer

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

July 4, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

3.8 years

First QC Date

April 10, 2008

Results QC Date

November 21, 2013

Last Update Submit

July 9, 2014

Conditions

Lung Cancer

Keywords

Extensive Disease-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    1.5 years after last subject enrolled

Secondary Outcomes (2)

  • Progression-Free Survival

    1.5 years after last subject enrolled

  • Objective Response Rate

    participants were followed for the duration of the study, an average of 12 weeks

Other Outcomes (1)

  • Overall Survival at 6 and 12 Months

    6 and 12 months.

Study Arms (2)

1

EXPERIMENTAL

Amrubicin Hydrochloride-Cisplatin combined chemotherapy

Drug: Amrubicin Hydrochloride

2

ACTIVE COMPARATOR

Etoposide-Cisplatin combined chemotherapy

Drug: Etoposide-Cisplatin combined chemotherapy

Interventions

Amrubicin HydrochlorideDRUG

Amrubicin Hydrochloride combined with cisplatin

1
Etoposide-Cisplatin combined chemotherapyDRUG

combined chemotherapy

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Fuzhou, Fujian, China

Location

Unknown Facility

Lanzhou, Gansu, China

Location

Unknown Facility

Guangzhou, Guangdong, China

Location

Unknown Facility

Changsha, Hunan, China

Location

Unknown Facility

Nanjing, Jiangsu, China

Location

Unknown Facility

Nanchang, Jiangxi, China

Location

Unknown Facility

Changchun, Jilin, China

Location

Unknown Facility

Dalian/Shenyang, Liaoning, China

Location

Unknown Facility

Shenyang, Liaoning, China

Location

Unknown Facility

Xian, Shanxi, China

Location

Unknown Facility

Chengdu, Sichuan, China

Location

Unknown Facility

Hangzhou, Zhejiang, China

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Tianjin, China

Location

Related Publications (1)

  • 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.

    PMID: 27061082DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

amrubicin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr.Sunyan
Organization
Cancer Hospital of Chinese Academy of Medical Sciences
suny@csco.org.cn
86-10-87788519

Study Officials

  • Yan Sun, MD

    Cancer Hospital Chinese Academy of Medical Science

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 17, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2012

Study Completion

August 1, 2012

Last Updated

July 18, 2014

Results First Posted

July 4, 2014

Record last verified: 2014-07

Locations

CN(15)