VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00450255
First received: March 20, 2007
Last updated: February 2, 2015
Last verified: April 2013
Results First Received: April 22, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ciliary Body and Choroid Melanoma, Medium/Large Size
Extraocular Extension Melanoma
Iris Melanoma
Metastatic Intraocular Melanoma
Recurrent Intraocular Melanoma
Recurrent Melanoma
Stage III Melanoma
Stage IV Melanoma
Interventions: Biological: ziv-aflibercept
Other: pharmacological study

  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
Arm I

Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given IV

pharmacological study: Correlative studies


Participant Flow:   Overall Study
    Arm I  
STARTED     41  
COMPLETED     40  
NOT COMPLETED     1  
Prior RFA ablation of liver                 1  



  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
Arm I

Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given IV

pharmacological study: Correlative studies


Baseline Measures
    Arm I  
Number of Participants  
[units: participants]
  41  
Age  
[units: years]
Median (Full Range)
  57   (23 to 84)  
Gender  
[units: participants]
 
Female     15  
Male     26  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     41  
Region of Enrollment  
[units: participants]
 
United States     41  



  Outcome Measures
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1.  Primary:   Objective Response Rate (CR + PR)   [ Time Frame: Start of treatment to disease progression/recurrence, up to 5 years ]

2.  Primary:   4 Month PFS Rate in Comparison With Historical Data   [ Time Frame: 4 months ]

3.  Secondary:   Overall Survival   [ Time Frame: From the initial date of treatment to the recorded date of death, assessed up to 5 years ]

4.  Secondary:   Toxicities Assessed Using NCI CTCAE v3.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Impact of the VEGF Trap Therapy on Laboratory Correlates   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting 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 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: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450255     History of Changes
Other Study ID Numbers: NCI-2009-00182, NCI-2009-00182, PHII-77, CDR0000535719, PHII-77, 7522, N01CM62209, P30CA033572
Study First Received: March 20, 2007
Results First Received: April 22, 2014
Last Updated: February 2, 2015
Health Authority: United States: Food and Drug Administration