Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT01118065
- Lead Sponsor
- Leiden University Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy
- Secondary Outcome Measures
Name Time Method Activity time to event endpoints Toxicity Maximum percentage of tumor reduction
Trial Locations
- Locations (1)
Leiden University Medical Center
🇳🇱Leiden, Netherlands