Evaluating the Combination of Everolimus and Sorafenib in the Treatment of Thyroid Cancer (NCT01141309)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and everolimus will have on your thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer. Sorafenib is pill that is approved by the FDA for the treatment of kidney and liver cancers. Sorafenib may work in many different ways. It helps decrease the blood supply to tumors. By doing so, it may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Everolimus is an oral medication that is FDA approved for the treatment of kidney cancer. It inhibits a protein kinase called mTOR ("mammalian Target of Rapamycin"). In laboratory studies, the addition of everolimus to sorafenib works better than sorafenib alone. These two drugs are being used together to treat other types of cancer in other clinical studies. In addition, the cancer will be evaluated to help us find factors that can help predict who would benefit most from this combination of drugs.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (23 items) and avoid the listed exclusions (31 items).
Location: Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Anaplastic thyroid carcinoma present in any biopsy or fine needle aspirate specimen over the previous year, unless a pathologist at MSKCC disagrees with this diagnosis.
- Previous treatment with a known mTOR inhibitor (e.g., everolimus, temsirolimus) or sorafenib for thyroid cancer.
- Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
- Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
- Patients may not be receiving any other investigational agents.
- Patients with known history of active intraparenchymal brain metastasis within previous 3 months. Previously treated lesions are eligible if they either have been surgically removed and there are no indications of metastatic disease on imaging of the brain or if there has been no progression after treatment for at least 6 months.
- Serious or non-healing wound, ulcer, or bone fracture.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 or sorafenib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey
- Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York
- Memorial Sloan Kettering Westchester — Harrison, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.