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

NCT ID: NCT01118065

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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everolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Ellen Kapiteijn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Facility Contacts

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Contact Person

Role: primary

References

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de Wit D, Schneider TC, Moes DJ, Roozen CF, den Hartigh J, Gelderblom H, Guchelaar HJ, van der Hoeven JJ, Links TP, Kapiteijn E, van Erp NP. Everolimus pharmacokinetics and its exposure-toxicity relationship in patients with thyroid cancer. Cancer Chemother Pharmacol. 2016 Jul;78(1):63-71. doi: 10.1007/s00280-016-3050-6. Epub 2016 May 11.

Reference Type DERIVED
PMID: 27169792 (View on PubMed)

Other Identifiers

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CDR0000672171

Identifier Type: REGISTRY

Identifier Source: secondary_id

EUDRACT-2009-016669-27

Identifier Type: -

Identifier Source: secondary_id

EU-21037

Identifier Type: -

Identifier Source: secondary_id

NL-31245-058-10

Identifier Type: -

Identifier Source: secondary_id

DUT-LUMC-CRAD001CNL08T

Identifier Type: -

Identifier Source: org_study_id