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

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.
 
ClinicalTrials.gov Identifier: NCT00286169
Recruitment Status : Terminated
First Posted : February 3, 2006
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
Sumitomo Dainippon Pharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 1, 2006
First Posted Date  ICMJE February 3, 2006
Last Update Posted Date August 10, 2010
Study Start Date  ICMJE April 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2006)
Overall survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2007)
  • Time to progression
  • Objective tumor response
  • Quality of Life (QOL: EuroQOL, FACT-L-LCS)
  • Frequency and severity of adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2006)
Time to progression, Objective tumor response, QOL (EuroQOL, FACT-L-LCS), Frequency and severity of adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
Official Title  ICMJE Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small-cell Lung Cancer
Intervention  ICMJE Drug: Amrubicin Hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: February 1, 2006)
130
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00286169
Other Study ID Numbers  ICMJE D0702002
JapicCTI-060203
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Sumitomo Dainippon Pharma Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Drug Development Division Dainippon Sumitomo Pharma Co., Ltd.
PRS Account Sumitomo Dainippon Pharma Co., Ltd.
Verification Date August 2010

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