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

Inclusion Criteria

• Histopathologically confirmed differentiated thyroid carcinoma of follicular cell origin, including any of the following histologies and their respective variants:
• Papillary
• Follicular
• Hürthle cell
• Must have surgically inoperable and/or recurrent or metastatic disease
• At least one fludeoxyglucose F 18 (FDG)-PET-avid lesion, defined as any focus of increased FDG uptake > normal mediastinal activity with standard uptake variable (SUV) maximum levels ≥ 3, as documented by baseline PET scan
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Progressive disease, defined by ≥ 1 of the following occurring during or after prior treatment (e.g., radioactive isotope [RAI] treatment):
• Presence of new or progressive lesions on CT scan or MRI
• New lesions on bone scan or PET scan
• Rising thyroglobulin level documented by a minimum of 3 consecutive rises, with an interval of > 1 week between each determination
• No known history of brain metastasis
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• ANC ≥ 1,500/mcL
• Platelet count ≥ 75,000/mcL
• WBC ≥ 3,000/mcL
• Total bilirubin ≤ 1.5 times upper limit of normal(ULN)
• AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)
• Creatinine ≤ 1.5 times ULNOR creatinine clearance ≥ 60 mL/min
• INR ≤ 1.2 (≤ 1.5 times ULN if on prophylactic-dose anticoagulation)
• Urine protein: creatinine ratio 3 months prior to initiation of therapy on this protocol and evidence of progression (as defined above) has been documented in the interim
• A diagnostic study using 1.5 allowed provided that both of the following criteria are met:
• In-range INR appropriate to the treatment indication (e.g., between 2 and 3 for atrial fibrillation) AND on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
• No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
• Patients receiving concurrent antihypertensive agents must have documentation of the date of the last change in dosage
• No other concurrent investigational agents
• No major surgical procedure or open biopsy within the past 28 days
• No anticipation of need for major surgical procedures during the course of the study