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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01118065
• Other study ID #: DUT-LUMC-CRAD001CNL08T
• Secondary ID: CDR0000672171EUD
• Status: Recruiting
• Phase: Phase 2
• First received: May 5, 2010
• Last updated: August 9, 2013
• Start date: May 2010

Study information

• Verified date: May 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• everolimus

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy			No
Secondary	Maximum percentage of tumor reduction			No
Secondary	Activity time to event endpoints			No
Secondary	Toxicity			Yes