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Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT01164176
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: everolimus Other: laboratory biomarker analysis Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer
Study Start Date : March 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Experimental: RAD001 group Drug: everolimus Other: laboratory biomarker analysis



Primary Outcome Measures :
  1. Response rate [ Time Frame: every 3 month ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: participants will be followed until death ]
  2. Progression-free survival [ Time Frame: participants will be followed until disease progression or death ]
  3. Toxicity profile [ Time Frame: participants will be followed until disease progression or death ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT01164176


Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Gyeonggi-do, Korea, Republic of, 431-070
Yeungnam University Medical Center
Daegu, Korea, Republic of, 712-749
National Cancer Center - Korea
Goyang, Korea, Republic of, 410-769
Kosin Medical Center Gospel Hospital
Pusan, Korea, Republic of, 602-702
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, Korea, Republic of, 120-752
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Byung Chul Cho Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01164176     History of Changes
Other Study ID Numbers: 4-2009-0542
YONSEI-CRAD001CKR12T
KCSG-HN-10-03
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: February 2014

Keywords provided by Yonsei University:
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

Additional relevant MeSH terms:
Thyroid Diseases
Head and Neck Neoplasms
Thyroid Neoplasms
Endocrine System Diseases
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents