Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

November 26, 2014 updated by: Yonsei University

An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Gyeonggi-do, Korea, Republic of, 431-070
        • Hallym University Sacred Heart Hospital
      • Daegu, Korea, Republic of, 712-749
        • Yeungnam University Medical Center
      • Goyang, Korea, Republic of, 410-769
        • National Cancer Center - Korea
      • Pusan, Korea, Republic of, 602-702
        • Kosin Medical Center Gospel Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 135-720
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 120-752
        • Yonsei Cancer Center at Yonsei University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAD001 group
Other: laboratory biomarker analysis
Drug: everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: every 3 month
every 3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity profile
Time Frame: participants will be followed until disease progression or death
participants will be followed until disease progression or death
Overall survival
Time Frame: participants will be followed until death
participants will be followed until death
Progression-free survival
Time Frame: participants will be followed until disease progression or death
participants will be followed until disease progression or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Byung Chul Cho, Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 15, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0542
  • YONSEI-CRAD001CKR12T
  • KCSG-HN-10-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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