Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer.
Temsirolimus is an intravenous medication that is FDA approved for other type of cancers. In laboratory studies, the addition of temsirolimus to sorafenib works better than sorafenib alone.
|Study Design:||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 Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer|
- Determine the objective response rate of the combination sorafenib and temsirolimus in I-131 refractory thyroid cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Evaluate if the presence of BRAF mutations, with or without concomitant mutations in the PI3K AKT, mTOR pathway, predict response to therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Determine progression-free survival under the combination sorafenib and temsirolimus in I-131 refractory thyroid cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Evaluate safety and tolerability for the combination sorafenib and temsirolimus in I-131 refractory thyroid cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Pts getting Temsirolimus and Sorafenib
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 4 weeks, or at the discretion of the treating physician or patient.
Drug: Temsirolimus and Sorafenib
Treatment will be with sorafenib 200 mg orally twice a day and temsirolimus 25 mg intravenous weekly. A cycle will be equivalent to 4 weeks of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025453
|United States, New Jersey|
|Memorial Sloan-Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|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|
|Memorial Sloan-Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Eric Sherman, MD||Memorial Sloan Kettering Cancer Center|