Spots Global Cancer Trial Database for Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

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Trial Identification

Brief Title: Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

Official Title: A Phase II Study to Investigate the Efficacy of RAD001 (Afinitor®, Everolimus) in Patients With Irresectable Recurrent or Metastatic Differentiated, Undifferentiated (Anaplastic) and Medullary Thyroid Carcinoma

Study ID: NCT01118065

Conditions

Head and Neck Cancer

Interventions

everolimus

Study Description

Brief Summary: 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.

Detailed Description: 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.