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Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729157
First Posted: August 7, 2008
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: February 26, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Thyroid Gland Carcinoma
Stage III Thyroid Gland Follicular Carcinoma
Stage III Thyroid Gland Papillary Carcinoma
Stage IV Thyroid Gland Follicular Carcinoma
Stage IV Thyroid Gland Papillary Carcinoma
Interventions: Radiation: Fludeoxyglucose F-18
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Procedure: Positron Emission Tomography
Biological: Ziv-Aflibercept

  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
Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.

Participant Flow:   Overall Study
    Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)
STARTED   41 
COMPLETED   40 
NOT COMPLETED   1 
Withdrawal by Subject                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.
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Reporting Groups
  Description
Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.

Baseline Measures
   Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) 
Overall Participants Analyzed 
[Units: Participants]
 41 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      20  48.8% 
>=65 years      21  51.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      22  53.7% 
Male      19  46.3% 
Region of Enrollment 
[Units: Participants]
 
United States   41 


  Outcome Measures
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1.  Primary:   Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate   [ Time Frame: 6 months ]

2.  Primary:   Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy   [ Time Frame: After 8 weeks of study therapy ]

3.  Secondary:   The Safety and Toxicity Profile of IV VEGF Trap in Patients With Recurrent and/or Metastatic TC-FCO   [ Time Frame: From the beginning of treatment through 30 days until participant comes off study ]

4.  Secondary:   To Determine the Biologic Effect of IV VEGF Trap on FDG Avidity After Four Cycles (Approximately 8 Weeks) of Therapy Through Pre- and Post-treatment FDG-PET Scans in Patients With Recurrent and/or Metastatic D-TC-FCO.   [ Time Frame: 8 weeks ]

5.  Secondary:   Effect of Thyroglobulin Concentration on Progression-free Survival   [ Time Frame: 6 months ]

6.  Other Pre-specified:   To Determine if Pre-treatment Serum VEGF Concentration Correlates With Clinical Outcomes After IV VEGF Trap Therapy in Patients With Recurrent and/or Metastatic D-TC-FCO.   [ Time Frame: Baseline-6 months post treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   To Determine if Changes in Thyroglobulin Concentration After Four Cycles (Approximately 8 Weeks) of IV VEGF-Trap Therapy Correlate With Radiographic Response After Four Cycles (Approximately 8 Weeks)   [ Time Frame: 8 weeks ]
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
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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: Dr. David Pfister
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4237
e-mail: pfisterd@mskcc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00729157     History of Changes
Other Study ID Numbers: NCI-2009-00178
NCI-2009-00178 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MSKCC-08066
CDR0000608163
08-066 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
7508 ( Other Identifier: CTEP )
N01CM62206 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
First Submitted: August 6, 2008
First Posted: August 7, 2008
Results First Submitted: February 26, 2016
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017