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Alliance A091302

Status:

Recruiting | Phase II

Official Title:

Randomized Phase II Study of Sorafenib With or Without Everolimus in Patients with Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer

Study Purpose:

To determine if adding everolimus, a chemotherapy drug, to the standard treatment for radioactive iodine refractory Hurthle thyroid cancer will control the cancer longer than the standard treatment alone. 

Interventions:

  • Study agents: Everolimus, Sorafenib
  • ARM 1: Sorafenib orally twice a day.  If the cancer gets worse on this treatment, subjects can re-register and start taking Everolimus orally once a day.
  • ARM 2: Sorafenib orally twice a day and everolimus orally once a day
    Patients will stay on study therapy until their cancer gets worse.  After completion of study therapy, patients are followed for up to 5 years after study enrollment.   

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Radioactive iodine refractory Hurthle cell thyroid cancer

Eligibility:

Patients must have metastatic disease or locally advanced disease that cannot be removed with surgery.

Patients must have radioactive iodine refractory disease.

Patients may have received any number of prior therapies as long as they did not include sorafenib or an mTOR inhibitor.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

A091302

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!