Status:
COMPLETED
Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer
Lead Sponsor:
Yonsei University
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 w...
Detailed Description
OBJECTIVES: Primary * To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus. Secondary * To evaluate overall ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01164176
Start Date
March 1 2010
End Date
October 1 2014
Last Update
December 2 2014
Active Locations (7)
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1
Hallym University Sacred Heart Hospital
Anyang, Gyeonggi-do, South Korea, 431-070
2
Yeungnam University Medical Center
Daegu, South Korea, 712-749
3
National Cancer Center - Korea
Goyang, South Korea, 410-769
4
Kosin Medical Center Gospel Hospital
Pusan, South Korea, 602-702