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Trial Title:
Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
NCT ID:
NCT01118065
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Everolimus
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
Overall status:
Unknown status
Study design:
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
everolimus
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2300 RC
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
31-71-526-3486
Email:
h.w.kapiteijn@lumc.nl
Start date:
May 2010
Lead sponsor:
Agency:
Leiden University Medical Center
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01118065
