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Trial record 1 of 1 for:    NCT01118065
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Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT01118065
Recruitment Status : Unknown
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 6, 2010
Last Update Posted : August 12, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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 progressive or recurrent, unresectable, or metastatic thyroid cancer.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: everolimus Phase 2

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2010
Estimated Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Efficacy

Secondary Outcome Measures :
  1. Maximum percentage of tumor reduction
  2. Activity time to event endpoints
  3. Toxicity

Eligibility Criteria
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Information from the National Library of Medicine

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

PATIENT CHARACTERISTICS:

  • Karnofsky performance score 70-100%
  • ANC ≥ 1,500/mm^³
  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Contacts and Locations
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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): NCT01118065


Locations
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Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300 RC
Contact: Contact Person    31-71-526-3486    h.w.kapiteijn@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center
Investigators
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Principal Investigator: Ellen Kapiteijn, MD, PhD Leiden University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT01118065    
Other Study ID Numbers: DUT-LUMC-CRAD001CNL08T
CDR0000672171 ( Registry Identifier: PDQ (Physician Data Query) )
EUDRACT-2009-016669-27
EU-21037
NL-31245-058-10
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: May 2010
Keywords provided by National Cancer Institute (NCI):
anaplastic 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:
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Head and Neck Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Everolimus
 MTOR Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents