Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer
NCT ID: NCT01164176
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2010-03-31
2014-10-31
Brief Summary
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PURPOSE: This phase II trial is studying how well everolimus works in treating patients with locally advanced or metastatic thyroid cancer.
Detailed Description
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Primary
* To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus.
Secondary
* To evaluate overall survival of these patients treated with everolimus.
* To evaluate progression-free survival of these patients.
* To evaluate toxicity of this therapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative studies.
After completion of study treatment, patients are followed up for 12 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RAD001 group
everolimus
laboratory biomarker analysis
Interventions
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everolimus
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed thyroid cancer
* Progressive or refractory disease within the past 6 months
* Locally advanced or metastatic disease
* Measurable disease, defined as ≥ 1 measurable lesion defined by RECIST criteria
* Not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy
* No untreated brain metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Creatinine \< 1.5 mg/dL
* Total bilirubin ≤ 1.0 times upper limit of normal (ULN)
* ALT and AST ≤ 3.0 times ULN
* No known hypersensitivity to the study drug
* No serious uncontrolled systemic intercurrent illness (e.g., infection or poorly controlled diabetes)
* No history of significant neurological or mental disorder, including seizures or dementia
* No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin
* No active uncontrolled cardiac disease
* No myocardial infarction within the past 12 months
* Able to take oral medication
* No active peptic ulcer disease
* Must have patient compliance and geographic proximity for adequate follow-up
PRIOR CONCURRENT THERAPY:
* At least 30 days since prior mTor-inhibitor therapy (e.g., temsirolimus) or non-hormonal anticancer therapy
* At least 2 weeks since prior and no concurrent P-glycoprotein, CYP3A4, and CYP3A5 inhibitors or inducers
* No prior surgical procedure affecting absorption
* No other concurrent systemic chemotherapy, investigational drug, or radiotherapy
18 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Byung Chul Cho
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
Locations
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Hallym University Sacred Heart Hospital
Anyang, Gyeonggi-do, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
National Cancer Center - Korea
Goyang, , South Korea
Kosin Medical Center Gospel Hospital
Pusan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Countries
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References
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Lim SM, Chang H, Yoon MJ, Hong YK, Kim H, Chung WY, Park CS, Nam KH, Kang SW, Kim MK, Kim SB, Lee SH, Kim HG, Na II, Kim YS, Choi MY, Kim JG, Park KU, Yun HJ, Kim JH, Cho BC. A multicenter, phase II trial of everolimus in locally advanced or metastatic thyroid cancer of all histologic subtypes. Ann Oncol. 2013 Dec;24(12):3089-94. doi: 10.1093/annonc/mdt379. Epub 2013 Sep 19.
Other Identifiers
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YONSEI-CRAD001CKR12T
Identifier Type: -
Identifier Source: secondary_id
KCSG-HN-10-03
Identifier Type: -
Identifier Source: secondary_id
4-2009-0542
Identifier Type: -
Identifier Source: org_study_id