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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

Ellen Kapiteijn, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Leiden University Medical Center

Authority:

Unspecified

Study ID:

CDR0000672171

NCT ID:

NCT01118065

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Thyroid Neoplasms
  • Head and Neck Neoplasms

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