RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with progressive or recurrent, unresectable, or metastatic thyroid cancer.
OBJECTIVES: Primary * To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma. Secondary * To determine maximum percentage of tumor reduction in these patients. * To describe activity time to event endpoints. * To assess toxicity. * To determine evolution of serum thyroglobulin. * To perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory) * To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer. OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Leiden University Medical Center
Leiden, Netherlands
RECRUITINGEfficacy
Maximum percentage of tumor reduction
Activity time to event endpoints
Toxicity
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