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

This study has been terminated.
Sponsor:
Information provided by:
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT00286169
First received: February 1, 2006
Last updated: August 9, 2010
Last verified: August 2010

February 1, 2006
August 9, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00286169
D0702002, JapicCTI-060203
Not Provided
Not Provided
Dainippon Sumitomo Pharma
Not Provided
Study Director: Drug Development Division Dainippon Sumitomo Pharma Co., Ltd.
Dainippon Sumitomo Pharma
August 2010

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