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

L

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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