Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Everolimus; Sirolimus

Criteria

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