Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

Head and Neck Cancer Clinical Trial

Official title:

An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164176
• Other study ID #: 4-2009-0542
• Secondary ID: YONSEI-CRAD001CK
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2010
• Last updated: November 26, 2014
• Start date: March 2010
• Est. completion date: October 2014

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• 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 locally advanced or metastatic thyroid cancer.

Description:

OBJECTIVES:

Primary

• To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus.

Secondary

• To evaluate overall survival of these patients treated with everolimus.

• To evaluate progression-free survival of these patients.

• To evaluate toxicity of this therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for correlative studies.

After completion of study treatment, patients are followed up for 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed thyroid cancer

• Progressive or refractory disease within the past 6 months

• Locally advanced or metastatic disease

• Measurable disease, defined as = 1 measurable lesion defined by RECIST criteria

• Not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy

• No untreated brain metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 3 months

• ANC = 1,500/mm³

• Platelet count = 100,000/mm³

• Hemoglobin = 9.0 g/dL

• Creatinine < 1.5 mg/dL

• Total bilirubin = 1.0 times upper limit of normal (ULN)

• ALT and AST = 3.0 times ULN

• No known hypersensitivity to the study drug

• No serious uncontrolled systemic intercurrent illness (e.g., infection or poorly controlled diabetes)

• No history of significant neurological or mental disorder, including seizures or dementia

• No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin

• No active uncontrolled cardiac disease

• No myocardial infarction within the past 12 months

• Able to take oral medication

• No active peptic ulcer disease

• Must have patient compliance and geographic proximity for adequate follow-up

PRIOR CONCURRENT THERAPY:

• At least 30 days since prior mTor-inhibitor therapy (e.g., temsirolimus) or non-hormonal anticancer therapy

• At least 2 weeks since prior and no concurrent P-glycoprotein, CYP3A4, and CYP3A5 inhibitors or inducers

• No prior surgical procedure affecting absorption

• No other concurrent systemic chemotherapy, investigational drug, or radiotherapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• everolimus

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang, Gyeonggi-do
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	National Cancer Center - Korea	Goyang
Korea, Republic of	Kosin Medical Center Gospel Hospital	Pusan
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei Cancer Center at Yonsei University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		every 3 month	No
Secondary	Overall survival		participants will be followed until death	No
Secondary	Progression-free survival		participants will be followed until disease progression or death	No
Secondary	Toxicity profile		participants will be followed until disease progression or death	Yes