NCT01118065

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

August 12, 2013

Status Verified

May 1, 2010

Enrollment Period

2 years

First QC Date

May 5, 2010

Last Update Submit

August 9, 2013

Conditions

Head and Neck Cancer

Keywords

anaplastic thyroid cancerrecurrent thyroid cancerstage III follicular thyroid cancerstage III papillary thyroid cancerstage IV follicular thyroid cancerstage IV papillary thyroid cancerthyroid gland medullary carcinoma

Outcome Measures

Primary Outcomes (1)

  • Efficacy

Secondary Outcomes (3)

  • Maximum percentage of tumor reduction

  • Activity time to event endpoints

  • Toxicity

Interventions

everolimusDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27169792DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsThyroid Carcinoma, AnaplasticThyroid NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, PapillaryCarcinoma, Medullary

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinomaAdenocarcinoma, PapillaryCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Ellen Kapiteijn, MD, PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 6, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Last Updated

August 12, 2013

Record last verified: 2010-05

Locations

NL(1)