S0435: Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00182689
First received: September 15, 2005
Last updated: January 4, 2013
Last verified: January 2013
Results First Received: August 20, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Intervention: Drug: sorafenib

  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
Platinum-Sensitive Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
Platinum-Refractory Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.

Participant Flow:   Overall Study
    Platinum-Sensitive     Platinum-Refractory  
STARTED     40     49  
Eligible     39     45  
Eligible and Began Protocol Therapy     38     45  
COMPLETED     0     0  
NOT COMPLETED     40     49  
Adverse Event                 8                 11  
Withdrawal by Subject                 2                 2  
Progression                 27                 29  
Death                 1                 0  
not protocol specified                 0                 3  
Ineligible                 1                 4  
Never received treatment                 1                 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
Platinum-Sensitive Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
Platinum-Refractory Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
Total Total of all reporting groups

Baseline Measures
    Platinum-Sensitive     Platinum-Refractory     Total  
Number of Participants  
[units: participants]
  38     45     83  
Age  
[units: years]
Median ( Full Range )
  65  
  ( 48 to 85 )  
  60  
  ( 44 to 80 )  
  62  
  ( 44 to 85 )  
Gender  
[units: participants]
     
Female     18     18     36  
Male     20     27     47  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     2     3  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     35     41     76  
More than one race     1     0     1  
Unknown or Not Reported     0     1     1  
Sites of Metastases  
[units: participants]
     
Single organ     4     7     11  
Multiple organs     32     34     66  
None     1     3     4  
Not reported     1     1     2  
Performance Status [1]
[units: participants]
     
0     15     15     30  
1     22     29     51  
Not reported     1     1     2  
Smoking History  
[units: participants]
     
Current     17     25     42  
Former     21     19     40  
Never     0     0     0  
Not reported     0     1     1  
Weight Loss Prior 6 Months  
[units: participants]
     
< 5%     26     31     57  
5% to < 10%     5     6     11  
10% to < 20%     1     5     6  
> or = 20%     1     1     2  
Not reported     5     2     7  
[1] Performance status is graded according to the Zubrod Scale (0-4). 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2: Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of limited self-care, confined to bed/chair > 50% of waking hours. 4: Completely disabled; cannot carry on any self-care; totally confined to bed/chair.



  Outcome Measures
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1.  Primary:   Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)   [ Time Frame: 8 weeks to 2 years ]

2.  Secondary:   Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Patients were assessed for adverse events after completion of every 28-day cycle. ]

3.  Secondary:   Overall Survival   [ Time Frame: 0 - 2 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


Publications of Results:
Gitlitz BJ, Glisson BS, Moon J, et al.: Sorafenib in patients with platinum (plat) treated extensive stage small cell lung cancer (E-SCLC): A SWOG (S0435) phase II trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-8039, 2008.


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00182689     History of Changes
Other Study ID Numbers: NCI-2012-03074, U10CA032102, S0435, CDR0000440068
Study First Received: September 15, 2005
Results First Received: August 20, 2012
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration