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First-line Treatment Of Subjects With Extensive Disease Small Cell Lung Cancer With Weekly Hycamtin And Paraplatin

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316186
First received: April 19, 2006
Last updated: October 20, 2009
Last verified: October 2009
History of Changes
Results First Received: April 29, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Small Cell Lung Cancer
Interventions: Drug: topotecan
Drug: carboplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intravenous Topotecan and Carboplatin Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days

Participant Flow:   Overall Study
    Intravenous Topotecan and Carboplatin  
STARTED     33  
COMPLETED     21  
NOT COMPLETED     12  
Adverse Event                 6  
Disease Progression                 4  
Lost to Follow-up                 1  
Other                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Intravenous Topotecan and Carboplatin Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days

Baseline Measures
    Intravenous Topotecan and Carboplatin  
Number of Participants  
[units: participants]
 		  33  
Age  
[units: years]
Mean ± Standard Deviation 		  62.2  ± 9.45  
Gender  
[units: participants]
 		 
Female     8  
Male     25  
Race/Ethnicity, Customized  
[units: participants]
 		 
White     33  



  Outcome Measures
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1.  Primary:   Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response   [ Time Frame: Baseline until up to Day 169 ]
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2.  Secondary:   Time to Response   [ Time Frame: From start of treatment to evidence of partial or complete response ]
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3.  Secondary:   Response Duration   [ Time Frame: From time of partial or complete response to disease progression/death ]
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4.  Secondary:   Time to Progression   [ Time Frame: From start of treatment to disease progression/death ]
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5.  Secondary:   Overall Survival, Calculated as the Number of Subjects Who Died From the Start of Treatment Until Follow-up   [ Time Frame: Week 1 up to maximum of Day 519 ]
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6.  Secondary:   Grade 1 (Mild) Hematological Toxicities   [ Time Frame: Week 1 through Endpoint (variable based on disease progression or toxicity) ]
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7.  Secondary:   Grade 2 (Moderate) Hematological Toxicities   [ Time Frame: Week 1 through Endpoint (variable based on disease progression or toxicity ]
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8.  Secondary:   Grade 3 (Severe) Hematological Toxicities   [ Time Frame: Week 1 through Endpoint (variable based on disease progression or toxicity ]
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9.  Secondary:   Grade 4 (Life-threatening or Disabling) Hematological Toxicities   [ Time Frame: Week 1 through Endpoint (variable based on disease progression or toxicity ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00316186     History of Changes
Other Study ID Numbers: 104864/903
Study First Received: April 19, 2006
Results First Received: April 29, 2009
Last Updated: October 20, 2009
Health Authority: United States: Food and Drug Administration