Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
Completed · Phase 2
Conditions studied: 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
In brief
This phase II trial is studying how well aflibercept works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine therapy. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor and by carrying tumor-killing substances directly to thyroid cancer cells.
Key facts
- Study ID
- NCT00729157
- Run by
- National Cancer Institute (NCI)
- People needed
- 41
- Starts
- 2008-08-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2017-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 < 1 OR 24-hour urine protein < 500 mg
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
- Documentation of systolic blood pressure ≤150 mm Hg and diastolic blood pressure ≤100 mm Hg
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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