Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00695292
First received: June 9, 2008
Last updated: February 22, 2013
Last verified: February 2013
Results First Received: January 14, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Small Cell Lung Cancer
Interventions: Drug: irinotecan
Drug: Carboplatin
Drug: sunitinib

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Irinotecan, Carboplatin, Sunitinib Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.

Participant Flow:   Overall Study
    Irinotecan, Carboplatin, Sunitinib  
STARTED     37  
COMPLETED     37  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Irinotecan, Carboplatin, Sunitinib Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.

Baseline Measures
    Irinotecan, Carboplatin, Sunitinib  
Number of Participants  
[units: participants]
  37  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     18  
>=65 years     19  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 9.9  
Gender  
[units: participants]
 
Female     16  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     37  



  Outcome Measures
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1.  Primary:   One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment   [ Time Frame: 18 months ]

2.  Secondary:   Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment   [ Time Frame: 18 months ]

3.  Secondary:   Efficacy and Safety Analysis Will be Conducted in Patients With Progressive Disease or Irreversible Toxicity on Chemotherapy Alone Who Elect to Receive Sunitinib Alone Until Progressive Disease or Irreversible Toxicity.   [ Time Frame: 18 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Dr. David Spigel
Organization: Sarah Cannon Research Institute
phone: 615-329-7274
e-mail: askSARAH@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00695292     History of Changes
Other Study ID Numbers: SCRI LUN 156
Study First Received: June 9, 2008
Results First Received: January 14, 2013
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration