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
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: everolimus
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 42
Study Start Date: May 2010
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118065

Locations
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
Principal Investigator: Ellen Kapiteijn, MD, PhD Leiden University Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01118065     History of Changes
Other Study ID Numbers: DUT-LUMC-CRAD001CNL08T, CDR0000672171, EUDRACT-2009-016669-27, EU-21037, NL-31245-058-10
Study First Received: May 5, 2010
Last Updated: August 9, 2013
Health Authority: Unspecified

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:
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Thyroid Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on July 31, 2014