Clinical trial NCT01164176: Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer
Official title: An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: anaplastic thyroid cancer
insular 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
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 well everolimus works in treating patients with locally advanced or metastatic thyroid cancer.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate
timeFrame: every 3 month
Secondary outcomes:
measure: Overall survival
timeFrame: participants will be followed until death
measure: Progression-free survival
timeFrame: participants will be followed until disease progression or death
measure: Toxicity profile
timeFrame: participants will be followed until disease progression or death
Other outcomes:
Locations:
city: Anyang, Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Goyang
country: Korea, Republic of
facility: National Cancer Center - Korea
city: Pusan
country: Korea, Republic of
facility: Kosin Medical Center Gospel Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center at Yonsei University Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Yonsei University
name: Byung Chul Cho
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.