Everolimus in Treating Patients With Locally Advanced 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 locally advanced or metastatic thyroid cancer.

Detailed Description
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OBJECTIVES: Primary To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus. Secondary To evaluate overall survival of these patients treated with everolimus. To evaluate progression-free survival of these patients. To evaluate toxicity of this therapy in these patients. OUTLINE: This is a multicenter study. Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for correlative studies. After completion of study treatment, patients are followed up for 12 months.

Official Title
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An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: everolimus
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed thyroid cancer Progressive or refractory disease within the past 6 months Locally advanced or metastatic disease Measurable disease, defined as ≥ 1 measurable lesion defined by RECIST criteria Not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy No untreated brain metastasis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 3 months ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9.0 g/dL Creatinine < 1.5 mg/dL Total bilirubin ≤ 1.0 times upper limit of normal (ULN) ALT and AST ≤ 3.0 times ULN No known hypersensitivity to the study drug No serious uncontrolled systemic intercurrent illness (e.g., infection or poorly controlled diabetes) No history of significant neurological or mental disorder, including seizures or dementia No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin No active uncontrolled cardiac disease No myocardial infarction within the past 12 months Able to take oral medication No active peptic ulcer disease Must have patient compliance and geographic proximity for adequate follow-up PRIOR CONCURRENT THERAPY: At least 30 days since prior mTor-inhibitor therapy (e.g., temsirolimus) or non-hormonal anticancer therapy At least 2 weeks since prior and no concurrent P-glycoprotein, CYP3A4, and CYP3A5 inhibitors or inducers No prior surgical procedure affecting absorption No other concurrent systemic chemotherapy, investigational drug, or radiotherapy

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAD001 group<br> | Drug: everolimus<br> <br> Other: laboratory biomarker analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | every 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | participants will be followed until death | 
| Progression-free survival |  | participants will be followed until disease progression or death | 
| Toxicity profile |  | participants will be followed until disease progression or death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anaplastic thyroid cancer, insular 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