Status:
COMPLETED
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
Lead Sponsor:
Sumitomo Pharma (Suzhou) Co., Ltd.
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 compare...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00660504
Start Date
April 1 2008
End Date
August 1 2012
Last Update
July 18 2014
Active Locations (15)
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1
Fuzhou, Fujian, China
2
Lanzhou, Gansu, China
3
Guangzhou, Guangdong, China
4
Changsha, Hunan, China