Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

Yonsei University

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: everolimus

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT01164176

KCSG-HN-10-03

YONSEI-CRAD001CKR12T

4-2009-0542

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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