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Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01164176
First received: July 15, 2010
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: everolimus
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Response rate [ Time Frame: every 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: participants will be followed until death ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: participants will be followed until disease progression or death ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: participants will be followed until disease progression or death ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 group Drug: everolimus Other: laboratory biomarker analysis

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164176

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang, Gyeonggi-do, Korea, Republic of, 431-070
Contact: Contact Person    82-31-380-3704      
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 712-749
Contact: Contact Person    82-53-620-4683      
National Cancer Center - Korea Recruiting
Goyang, Korea, Republic of, 410-769
Contact: Contact Person    82-31-920-1621      
Kosin Medical Center Gospel Hospital Recruiting
Pusan, Korea, Republic of, 602-702
Contact: Contact Person    82-51-990-6107      
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Contact Person    82-2-2019-3297      
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Contact Person    82-2-2072-3559      
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Contact Person    82-2-2228-8138    cbc1971@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Byung Chul Cho Yonsei University
  More Information

Additional Information:
No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01164176     History of Changes
Other Study ID Numbers: 4-2009-0542, YONSEI-CRAD001CKR12T, KCSG-HN-10-03
Study First Received: July 15, 2010
Last Updated: February 17, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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:
Head and Neck Neoplasms
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Thyroid Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014