Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
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
Study Type
Interventional
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: everolimus
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Leiden University Medical Center
Leiden, Netherlands
Status: Recruiting
Contact: Contact Person - 31-71-526-3486 - h.w.kapiteijn@lumc.nl
Start Date
May 2010
Sponsors
Leiden University Medical Center
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page