Clinical trial NCT01118065: Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
Official title: A Phase II Study to Investigate the Efficacy of RAD001 (Afinitor®, Everolimus) in Patients With Irresectable Recurrent or Metastatic Differentiated, Undifferentiated (Anaplastic) and Medullary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Cancer
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-05-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Efficacy
Secondary outcomes:
measure: Maximum percentage of tumor reduction
measure: Activity time to event endpoints
measure: Toxicity
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Ellen Kapiteijn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Wit D, Schneider TC, Moes DJ, Roozen CF, den Hartigh J, Gelderblom H, Guchelaar HJ, van der Hoeven JJ, Links TP, Kapiteijn E, van Erp NP. Everolimus pharmacokinetics and its exposure-toxicity relationship in patients with thyroid cancer. Cancer Chemother Pharmacol. 2016 Jul;78(1):63-71. doi: 10.1007/s00280-016-3050-6. Epub 2016 May 11.