Clinical trial NCT00660504: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: Extensive Disease-Small Cell Lung Cancer
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Survival
timeFrame: 1.5 years after last subject enrolled
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: 1.5 years after last subject enrolled
measure: Objective Response Rate
timeFrame: participants were followed for the duration of the study, an average of 12 weeks
Other outcomes:
measure: Overall Survival at 6 and 12 Months
timeFrame: 6 and 12 months.
Locations:
city: Fuzhou
country: China
state: Fujian
city: Lanzhou
country: China
state: Gansu
city: Guangzhou
country: China
state: Guangdong
city: Changsha
country: China
state: Hunan
city: Nanjing
country: China
state: Jiangsu
city: Nanchang
country: China
state: Jiangxi
city: Changchun
country: China
state: Jilin
city: Dalian/Shenyang
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Xian
country: China
state: Shanxi
city: Chengdu
country: China
state: Sichuan
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Shanghai
country: China
city: Tianjin
country: China
Study officials:
affiliation: Cancer hospital, Chinese Academy of Medical Science
name: Yan Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.