Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
Recruitment status was: Recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Maximum percentage of tumor reduction
- Activity time to event endpoints
|Study Start Date:||May 2010|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
- To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118065
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Principal Investigator:||Ellen Kapiteijn, MD, PhD||Leiden University Medical Center|