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Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

everolimus

laboratory biomarker analysis

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring anaplastic thyroid cancer, insular 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hallym University Sacred Heart Hospital
Yeungnam University Medical Center
National Cancer Center - Korea
Kosin Medical Center Gospel Hospital
Seoul National University Hospital
Yonsei Cancer Center at Yonsei University Medical Center
Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD001 group

Arm Description

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Overall survival

Progression-free survival

Toxicity profile

Full Information

NCT ID

NCT01164176

First Posted

July 15, 2010

Last Updated

November 26, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01164176

Brief Title

Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

anaplastic thyroid cancer, insular 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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RAD001 group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

everolimus

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Primary Outcome Measure Information:

Title

Response rate

Time Frame

every 3 month

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

participants will be followed until death

Title

Progression-free survival

Time Frame

participants will be followed until disease progression or death

Title

Toxicity profile

Time Frame

participants will be followed until disease progression or death

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Byung Chul Cho

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hallym University Sacred Heart Hospital

City

Anyang, Gyeonggi-do

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

Yeungnam University Medical Center

City

Daegu

ZIP/Postal Code

712-749

Country

Korea, Republic of

Facility Name

National Cancer Center - Korea

City

Goyang

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

Kosin Medical Center Gospel Hospital

City

Pusan

ZIP/Postal Code

602-702

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Yonsei Cancer Center at Yonsei University Medical Center

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Gangnam Severance Hospital

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

24050953

Citation

Lim SM, Chang H, Yoon MJ, Hong YK, Kim H, Chung WY, Park CS, Nam KH, Kang SW, Kim MK, Kim SB, Lee SH, Kim HG, Na II, Kim YS, Choi MY, Kim JG, Park KU, Yun HJ, Kim JH, Cho BC. A multicenter, phase II trial of everolimus in locally advanced or metastatic thyroid cancer of all histologic subtypes. Ann Oncol. 2013 Dec;24(12):3089-94. doi: 10.1093/annonc/mdt379. Epub 2013 Sep 19.

Results Reference

derived

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Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

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