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S0802 - Topotecan With or Without Aflibercept 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:
NCT00828139
First received: January 22, 2009
Last updated: March 2, 2016
Last verified: April 2014
Results First Received: November 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Extensive Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Interventions: Biological: ziv-aflibercept
Drug: topotecan hydrochloride

  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 Treated With Topotecan and Ziv-aflibercept Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
Platinum Sensitivity Treated With Topotecan Alone Patients with platinum sensitivity treated with topotecan alone
Platinum Refractory Treated With Topotecan + Ziv-aflibercept Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
Platinum Refractory Treated With Topotecan Aloine Patients with platinum refractory treated topotecan alone.

Participant Flow:   Overall Study
    Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept   Platinum Sensitivity Treated With Topotecan Alone   Platinum Refractory Treated With Topotecan + Ziv-aflibercept   Platinum Refractory Treated With Topotecan Aloine
STARTED   42   41   55   51 
COMPLETED   1   0   0   0 
NOT COMPLETED   41   41   55   51 
Adverse Event                8                1                10                5 
Death                2                1                0                2 
Refusal unrelated to toxicity                3                4                5                3 
Disease Progression                24                33                35                39 
Not specified                4                2                5                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.
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Reporting Groups
  Description
Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
Platinum Sensitivity Treated With Topotecan Alone Patients with platinum sensitivity treated with topotecan alone
Platinum Refractory Treated With Topotecan + Ziv-aflibercept Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
Platinum Refractory Treated With Topotecan Aloine Patients with platinum refractory treated topotecan alone.
Total Total of all reporting groups

Baseline Measures
   Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept   Platinum Sensitivity Treated With Topotecan Alone   Platinum Refractory Treated With Topotecan + Ziv-aflibercept   Platinum Refractory Treated With Topotecan Aloine   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   41   55   51   189 
Age 
[Units: Years]
Median (Full Range)
 63.4 
 (43.1 to 81.8) 
 60.1 
 (33.2 to 85.1) 
 60.9 
 (40.1 to 82.6) 
 63.6 
 (45.1 to 85.1) 
 62.5 
 (33.2 to 85.1) 
Gender 
[Units: Participants]
         
Female   25   28   29   17   99 
Male   17   13   26   34   90 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   36   40   49   43   168 
Black   4   1   3   4   12 
Pacific Islander   1   0   0   0   1 
Asian   0   0   0   1   1 
Native American   0   0   2   1   3 
Unknown/Other   1   0   1   2   4 
Metastatic Disease Sites 
[Units: Participants]
         
Single lesion, single organ   4   9   4   4   21 
Multiple lesions, single organ   11   9   9   11   40 
Multiple lesions, multiple organs   25   22   41   34   122 
None   2   1   1   2   6 
Stage [1] 
[Units: Participants]
         
Extensive   27   23   39   42   131 
Limited   15   18   16   9   58 
[1]

In limited stage small cell lung cancer, the cancer resides in one lung or in the nearby tissue.

In the extensive stage, cancer has spread to tissue outside of the originally affected lung.

Performance Status [1] 
[Units: Participants]
         
 14   17   12   19   62 
 28   24   43   32   127 
[1]

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.

The higher grade, the worse outcome.



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Disease assessments were performed every 6 weeks, up to 2 years. ]

2.  Secondary:   Overall Survival   [ Time Frame: Weekly, up to 2 years. ]

3.  Secondary:   Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses)   [ Time Frame: Disease assessment for response were performed every 6 weeks, up to 2 years. ]

4.  Secondary:   Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs   [ Time Frame: Toxicity assessment was evaluated after each cycle (21 days), up to 2 years. ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lung Committee Statistician
Organization: SWOG Statistical Center
phone: 2066674623
e-mail: jmoon@fredhutch.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00828139     History of Changes
Other Study ID Numbers: NCI-2009-01182
NCI-2009-01182 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S0802
CDR0000632614
S0802 ( Other Identifier: Southwest Oncology Group )
S0802 ( Other Identifier: CTEP )
Study First Received: January 22, 2009
Results First Received: November 5, 2015
Last Updated: March 2, 2016
Health Authority: United States: Food and Drug Administration