Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT01118065|
Recruitment Status : Unknown
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 6, 2010
Last Update Posted : August 12, 2013
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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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: everolimus||Phase 2|
- To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Masking:||None (Open Label)|
|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 Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2012|
- Maximum percentage of tumor reduction
- Activity time to event endpoints
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118065
|Leiden University Medical Center||Recruiting|
|Leiden, Netherlands, 2300 RC|
|Contact: Contact Person 31-71-526-3486 email@example.com|
|Principal Investigator:||Ellen Kapiteijn, MD, PhD||Leiden University Medical Center|
|Other Study ID Numbers:||
CDR0000672171 ( Registry Identifier: PDQ (Physician Data Query) )
|First Posted:||May 6, 2010 Key Record Dates|
|Last Update Posted:||August 12, 2013|
|Last Verified:||May 2010|
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
Head and Neck Neoplasms
Endocrine System Diseases
Neoplasms by Site
Endocrine Gland Neoplasms
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs