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Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286169
First Posted: February 3, 2006
Last Update Posted: August 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sumitomo Dainippon Pharma Co., Ltd.
February 1, 2006
February 3, 2006
August 10, 2010
April 2006
Not Provided
Overall survival
Same as current
Complete list of historical versions of study NCT00286169 on ClinicalTrials.gov Archive Site
  • Time to progression
  • Objective tumor response
  • Quality of Life (QOL: EuroQOL, FACT-L-LCS)
  • Frequency and severity of adverse events
Time to progression, Objective tumor response, QOL (EuroQOL, FACT-L-LCS), Frequency and severity of adverse events
Not Provided
Not Provided
 
Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer
The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small-cell Lung Cancer
Drug: Amrubicin Hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
130
Not Provided
Not Provided

Inclusion Criteria:

  • Extensive-disease small-cell lung cancer
  • Aged 70 years or older
  • Performance status of 0-2
  • No prior chemotherapy

Exclusion Criteria:

  • Prior therapy for primary lesion
  • Pneumonitis and/or pulmonary fibrosis
  • Active concomitant malignancy
Sexes Eligible for Study: All
70 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00286169
D0702002
JapicCTI-060203
Not Provided
Not Provided
Not Provided
Not Provided
Sumitomo Dainippon Pharma Co., Ltd.
Not Provided
Study Director: Drug Development Division Dainippon Sumitomo Pharma Co., Ltd.
Sumitomo Dainippon Pharma Co., Ltd.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP