Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer (NCT01164176) | Clinical Trial Compass
CompletedPhase 2
Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer
South Korea40 participantsStarted 2010-03
Plain-language 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 locally advanced or metastatic thyroid cancer.
Who can participate
Age range18 Years
SexALL
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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 in…