Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

Leiden University Medical Center (LUMC)

Status and phase: Unknown; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01118065

DUT-LUMC-CRAD001CNL08T

CDR0000672171 (Registry Identifier)

EUDRACT-2009-016669-27

EU-21037

NL-31245-058-10

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 progressive or recurrent, unresectable, or metastatic thyroid cancer.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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