Evaluating the Combination of Everolimus and Sorafenib in the Treatment of Thyroid Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Evaluating the Combination of Everolimus and Sorafenib in the Treatment of Thyroid Cancer|
- Determine the response rate of the combination sorafenib and everolimus. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Evaluate if mutations in the pTEN, PI3K AKT, mTOR pathway, predict response to therapy. [ Time Frame: done prior to the start of therapy and again 3-5 weeks after the start of treatment ] [ Designated as safety issue: No ]
- Determine the progression free survival under the combination of sorafenib and everolimus. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assess safety and toxicity. [ Time Frame: once a week ] [ Designated as safety issue: Yes ]This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: sorafenib with everolimus
This is a two-stage phase II study combining sorafenib with everolimus in patients with thyroid cancer.
Drug: sorafenib with everolimus
Treatment will be with sorafenib 400 mg orally twice a day and everolimus 5 mg orally daily. Restage every 2 cycles *Cycle = 4 weeks of treatment.
Subjects may consent to allowing blood to be drawn for DNA. Two blue top tubes will be required. Approximately 5-6 ml will be needed. This may be done at anytime, including before, during, or after treatment. This is not required to participate in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141309
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memoral Sloan Kettering Cancer Center at Phelps|
|Sleepy Hollow, New York, United States, 10591|
|Memorial Sloan Kettering West Harrison|
|West Harrison, New York, United States, 10604|
|Principal Investigator:||Eric Sherman, MD||Memorial Sloan Kettering Cancer Center.|