A Phase II Study of Single Agent Intravenous (IV) VEGF Trap in Patients With Poor Prognostic Recurrent and/or Metastatic Thyroid Cancer After RAI Therapy
I. To determine the radiographic response rate (by RECIST criteria) of IV VEGF Trap after
four cycles (approximately 8 weeks) of therapy, as well as the 6-month
progression-free-survival (PFS) rate (as part of a composite primary outcome measure), in
patients with recurrent and/or metastatic differentiated thyroid carcinoma of follicular
cell origin (D-TC-FCO; comprising papillary, follicular, Hurthle cell, and respective
variants) not amenable to RAI or curative surgery.
I. To determine the safety and toxicity profile of IV VEGF Trap in patients with recurrent
and/or metastatic TC-FCO.
II. 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.
III. 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) and progression-free-survival at 6 months after start of therapy in
patients with recurrent and/or metastatic D-TC-FCO.
IV. 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.
I. To determine population pharmacokinetics of IV VEGF Trap for patients with thyroid
II. To determine whether antibodies to VEGF Trap develop in patients with thyroid cancer.
Patients receive aflibercept intravenously (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 fludeoxyglucose F 18 (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.
After completion of study therapy, patients are followed up for 2-4 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Radiographic response rate of aflibercept in patients with recurrent and/or metastatic thyroid cancer that did not respond to radioactive iodine therapy
Assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed a minimum interval of 4 weeks after the criteria for response are first met.
After 8 weeks of study therapy
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
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