Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This study has been terminated.
(Extreme toxicity)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Afshin Dowlati, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00726986
First received: July 31, 2008
Last updated: July 8, 2014
Last verified: July 2014
Results First Received: July 8, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: cisplatin
Drug: etoposide
Drug: sorafenib tosylate

  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
A total of 18 patients were enrolled into the trial from 3 sites between August 2008 and November 2011. One patient withdrew during the screening process and was not included in the study. Patients were recruited from University Hospitals Case Medical Center and Cleveland Clinic in Cleveland Ohio and Columbia Presbyterian in New York.

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
Sorafenib, Cisplatin, and Etoposide Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.

Participant Flow for 2 periods

Period 1:   Induction Phase
    Sorafenib, Cisplatin, and Etoposide  
STARTED     18  
Maintance     3  
COMPLETED     3  
NOT COMPLETED     15  
Adverse Event                 4  
Withdrawal by Subject                 2  
Death                 2  
Lack of Efficacy                 5  
Secondary Disease                 2  

Period 2:   Maintenance Phase
    Sorafenib, Cisplatin, and Etoposide  
STARTED     3  
COMPLETED     0  
NOT COMPLETED     3  
Adverse Event                 1  
Lack of Efficacy                 2  



  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.
No text entered.

Reporting Groups
  Description
Sorafenib, Cisplatin, and Etoposide Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.

Baseline Measures
    Sorafenib, Cisplatin, and Etoposide  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 45 to 82 )  
Gender  
[units: participants]
 
Female     9  
Male     9  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     17  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival(PFS)   [ Time Frame: 1-year ]

2.  Secondary:   Median Overall Survival   [ Time Frame: 1-year ]

3.  Secondary:   Response Rate   [ Time Frame: reevaluated for response every 8 weeks ]

4.  Secondary:   Safety   [ Time Frame: Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity. ]


  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
This study was terminated after enrolling 18 patients on the basis of excessive toxicity observed and preliminary efficacy data showing that study was unlikely to meet primary end point.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Afshin Dowlati MD
Organization: Case Comprehensive Cancer Center
phone: 216-844-1228
e-mail: afshin.dowlati@uhhospitals.org


No publications provided


Responsible Party: Afshin Dowlati, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00726986     History of Changes
Other Study ID Numbers: CASE8507, P30CA043703, CASE8507, CASE-8507-CC486
Study First Received: July 31, 2008
Results First Received: July 8, 2014
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration