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Clinical Trials (PDQ®)

Phase II Study of Everolimus in Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Carcinoma. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentUnknown18 and overOtherDUT-LUMC-CRAD001CNL08T
LUMC-CRAD001CNL08T, EUDRACT-2009-016669-27, EU-21037, NL-31245-058-10, THYRRAD, NCT01118065

Objectives

Primary

  1. To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.

Secondary

  1. To determine maximum percentage of tumor reduction in these patients.
  2. To describe activity time to event endpoints.
  3. To assess toxicity.
  4. To determine evolution of serum thyroglobulin.
  5. To perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory)
  6. To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer.

Entry Criteria

Disease Characteristics:

  • Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria:
    • Progressive or recurrent disease
    • Metastatic disease
    • Unresectable disease

  • Meeting any of the following thyroid cancer subtypes:
    • Differentiated thyroid cancer (i.e., papillary, follicular, or Hurthle cell disease) that is radio-iodine refractory
    • Undifferentiated thyroid cancer (i.e., anaplastic disease)
    • Medullary thyroid cancer

  • Must have received prior everolimus or other mTOR inhibitor therapy

  • Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed

Prior/Concurrent Therapy:

  • See Disease Characteristics

Patient Characteristics:

  • Karnofsky performance score 70-100%
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 5.6 mmol/L
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for known liver metastases)
  • Serum creatinine ≤ 2 times ULN
  • Negative pregnancy test
  • No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years

Expected Enrollment

42

Outcomes

Primary Outcome(s)

Efficacy

Secondary Outcome(s)

Maximum percentage of tumor reduction
Activity time to event endpoints
Toxicity

Outline

Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

Leiden University Medical Center

Ellen Kapiteijn, MD, PhD, Principal investigator
Ph: 31-71-526-3486
Email: h.w.kapiteijn@lumc.nl

Registry Information
Official Title A Phase II Study to Investigate the Efficacy of RAD001 (Afinitor®, Everolimus) in Patients with Irresectable Recurrent or Metastatic Differentiated, Undifferentiated (Anaplastic) and Medullary Thyroid Carcinoma
Trial Start Date 2010-05-03
Trial Completion Date 2012-05-03 (estimated)
Registered in ClinicalTrials.gov NCT01118065
Date Submitted to PDQ 2010-04-27
Information Last Verified 2010-05-11

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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