Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: everolimus; Other: laboratory biomarker analysis

• Registration Number: NCT01164176
• Lead Sponsor: Yonsei University

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 locally advanced or metastatic thyroid cancer.

Detailed 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Status Verified: 2014-02
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-11-26
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RAD001 group	laboratory biomarker analysis	-
RAD001 group	everolimus	-

Primary Outcome Measures

Name	Time	Method
Response rate	every 3 month

Secondary Outcome Measures

Name	Time	Method
Overall survival	participants will be followed until death
Progression-free survival	participants will be followed until disease progression or death
Toxicity profile	participants will be followed until disease progression or death

Trial Locations

Locations (7)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Gyeonggi-do, Korea, Republic of

National Cancer Center - Korea; 🇰🇷 Goyang, Korea, Republic of

Yonsei Cancer Center at Yonsei University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kosin Medical Center Gospel Hospital; 🇰🇷 Pusan, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of