Full TitleRandomized Phase II Study of Sorafenib with or without Everolimus in Patients with Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer (Alliance A091302)
Radioactive iodine is a standard therapy for metastatic Hurthle cell thyroid cancer. If the cancer continues to grow despite this treatment, patients typically receive sorafenib. In this study, researchers want to see if giving sorafenib with another drug, everolimus, is more effective than sorafenib alone in patients with radioactive iodine-refractory Hurthle cell thyroid cancer.
Patients will be randomly assigned to one of two groups: sorafenib alone (with the potential to switch to everolimus alone if the cancer continues growing) or sorafenib plus everolimus. Sorafenib works by targeting several proteins involved in cancer growth. Everolimus inhibits a molecule called mTOR, which helps cancer cells grow. Both drugs are taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have Hurthle cell thyroid cancer that cannot be surgically removed or has spread, and continues to grow despite prior treatment with radioactive iodine.
- At least 90 days must pass between completion of radioactive iodine therapy and entry into the study.
- For patients who already received chemotherapy, at least 4 weeks must pass between completion of chemotherapy and study entry.
- Patients may not have previously received sorafenib or an mTOR inhibitor.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.