Head and Neck Cancer
Conditions
Keywords
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
Brief 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 progressive or recurrent, unresectable, or metastatic thyroid cancer.
Detailed description
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.
Interventions
DRUGeverolimus
Sponsors
Leiden University Medical Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum percentage of tumor reduction | — |
| Activity time to event endpoints | — |
| Toxicity | — |
Countries
Netherlands
Outcome results
None listed