Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

NCT01164176 | Completed Phase 2

• 3 other identifiers: 4-2009-0542YONSEI-CRAD001CKR12TKCSG-HN-10-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Response rate

  every 3 month

Secondary Outcomes (3)

• 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

Study Arms (1)

RAD001 group

EXPERIMENTAL

Drug: everolimus; Other: laboratory biomarker analysis

Interventions

everolimus DRUG

RAD001 group

laboratory biomarker analysis OTHER

RAD001 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (7)

Hallym University Sacred Heart Hospital

Anyang, Gyeonggi-do, 431-070, South Korea

Location

Yeungnam University Medical Center

Daegu, 712-749, South Korea

Location

National Cancer Center - Korea

Goyang, 410-769, South Korea

Location

Kosin Medical Center Gospel Hospital

Pusan, 602-702, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24050953 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Thyroid Carcinoma, Anaplastic; Thyroid Neoplasms; Adenocarcinoma, Follicular; Thyroid Cancer, Papillary; Carcinoma, Medullary

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma; Adenocarcinoma, Papillary; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Byung Chul Cho

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-02

Locations

KR (7)