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Ziv-Aflibercept in Treating Patients With Metastatic or Unresectable Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00357760
First received: July 26, 2006
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: February 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Metastatic Renal Cell Carcinoma
Intervention: Biological: VEGF Trap

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was activated on 12/21/2007 and closed to accrual on 12/6/2013 with a total accrual of 94 patients.

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
Arm A (Higher Dose of VEGF Trap) Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Arm B (Lower Dose of VEGF Trap) Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.

Participant Flow:   Overall Study
    Arm A (Higher Dose of VEGF Trap)   Arm B (Lower Dose of VEGF Trap)
STARTED   59   35 
Patients Who Started Treatment   57   34 
Eligible and Treated Patients   57   32 
Patients Who Undergo Dose Escalation   0 [1]   16 
COMPLETED   0 [2]   0 [2] 
NOT COMPLETED   59   35 
Disease progression                44                17 
Adverse Event                10                7 
Death                0                3 
Alternative therapy                1                0 
Withdrawal by Subject                0                2 
Never started treatment                2                1 
Ineligible                0                2 
Physician Decision                2                1 
Protocol Violation                0                1 
To receive hospice care                0                1 
[1] Only patients who progressed on the low dose (Arm B) had the opportunity to undergo dose escalation.
[2] Patients continued receiving protocol treatment until progressive disease or unacceptable toxicity.



  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.
Eligible and treated patients are included in this analysis.

Reporting Groups
  Description
Arm A (Higher Dose of VEGF Trap) Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Arm B (Lower Dose of VEGF Trap) Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
Total Total of all reporting groups

Baseline Measures
   Arm A (Higher Dose of VEGF Trap)   Arm B (Lower Dose of VEGF Trap)   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   32   89 
Age 
[Units: Years]
Median (Full Range)
 60 
 (35 to 80) 
 62 
 (33 to 73) 
 61 
 (33 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  24.6%      10  31.3%      24  27.0% 
Male      43  75.4%      22  68.8%      65  73.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients Alive and Progression-free at 8 Weeks   [ Time Frame: Assessed at 8 weeks ]

2.  Secondary:   Proportion of Patients With Objective Response   [ Time Frame: Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollment ]

3.  Secondary:   Progression-free Survival (PFS) Among Patients Who Undergo Dose Escalation Following Progression on Lower-dose VEGF Trap   [ Time Frame: Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollment ]

4.  Other Pre-specified:   Circulating Levels of VEGF-Trap Complex   [ Time Frame: Assessed at baseline, 4 weeks, 6 weeks, 8 weeks and end of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Angiogenesis-related Protein Expression   [ Time Frame: Assessed every 8 weeks during treatment and end of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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: Study Statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00357760     History of Changes
Other Study ID Numbers: NCI-2009-00559
NCI-2009-00559 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E4805 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA180820 ( US NIH Grant/Contract Award Number )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: July 26, 2006
Results First Received: February 8, 2017
Last Updated: April 7, 2017