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Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01118065
First received: May 5, 2010
Last updated: August 9, 2013
Last verified: May 2010

May 5, 2010
August 9, 2013
May 2010
May 2012   (final data collection date for primary outcome measure)
Efficacy [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01118065 on ClinicalTrials.gov Archive Site
  • Maximum percentage of tumor reduction [ Designated as safety issue: No ]
  • Activity time to event endpoints [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
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

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
Drug: everolimus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
Not Provided
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Netherlands
 
NCT01118065
DUT-LUMC-CRAD001CNL08T, CDR0000672171, EUDRACT-2009-016669-27, EU-21037, NL-31245-058-10
Not Provided
Not Provided
Leiden University Medical Center
Not Provided
Principal Investigator: Ellen Kapiteijn, MD, PhD Leiden University Medical Center
National Cancer Institute (NCI)
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP