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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: everolimus


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria: Progressive or recurrent disease Metastatic disease Unresectable disease Meeting any of the following thyroid cancer subtypes: Differentiated thyroid cancer (i.e., papillary, follicular, or Hurthle cell disease) that is radio-iodine refractory Undifferentiated thyroid cancer (i.e., anaplastic disease) Medullary thyroid cancer Must have received prior everolimus or other mTOR inhibitor therapy Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed PATIENT CHARACTERISTICS: Karnofsky performance score 70-100% ANC ≥ 1,500/mm^³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 5.6 mmol/L Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for known liver metastases) Serum creatinine ≤ 2 times ULN Negative pregnancy test No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: everolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum percentage of tumor reduction |  |  | 
| Activity time to event endpoints |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anaplastic thyroid cancer, recurrent thyroid cancer, stage III follicular thyroid cancer, stage III papillary thyroid cancer, stage IV follicular thyroid cancer, stage IV papillary thyroid cancer, thyroid gland medullary carcinoma