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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Amrubicin Hydrochloride
Etoposide-Cisplatin combined chemotherapy
Sponsored by
Sumitomo Pharma (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Extensive Disease-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Amrubicin Hydrochloride-Cisplatin combined chemotherapy

Etoposide-Cisplatin combined chemotherapy

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression-Free Survival
Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Full Information

First Posted
April 10, 2008
Last Updated
July 9, 2014
Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00660504
Brief Title
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
Official Title
Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Extensive Disease-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Etoposide-Cisplatin combined chemotherapy
Intervention Type
Drug
Intervention Name(s)
Amrubicin Hydrochloride
Intervention Description
Amrubicin Hydrochloride combined with cisplatin
Intervention Type
Drug
Intervention Name(s)
Etoposide-Cisplatin combined chemotherapy
Intervention Description
combined chemotherapy
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
1.5 years after last subject enrolled
Secondary Outcome Measure Information:
Title
Progression-Free Survival
Time Frame
1.5 years after last subject enrolled
Title
Objective Response Rate
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
participants were followed for the duration of the study, an average of 12 weeks
Other Pre-specified Outcome Measures:
Title
Overall Survival at 6 and 12 Months
Time Frame
6 and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Sun, MD
Organizational Affiliation
Cancer hospital, Chinese Academy of Medical Science
Official's Role
Principal Investigator
Facility Information:
City
Fuzhou
State/Province
Fujian
Country
China
City
Lanzhou
State/Province
Gansu
Country
China
City
Guangzhou
State/Province
Guangdong
Country
China
City
Changsha
State/Province
Hunan
Country
China
City
Nanjing
State/Province
Jiangsu
Country
China
City
Nanchang
State/Province
Jiangxi
Country
China
City
Changchun
State/Province
Jilin
Country
China
City
Dalian/Shenyang
State/Province
Liaoning
Country
China
City
Shenyang
State/Province
Liaoning
Country
China
City
Xian
State/Province
Shanxi
Country
China
City
Chengdu
State/Province
Sichuan
Country
China
City
Hangzhou
State/Province
Zhejiang
Country
China
City
Beijing
Country
China
City
Shanghai
Country
China
City
Tianjin
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27061082
Citation
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.
Results Reference
derived

Learn more about this trial

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

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