Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer
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.
Head and Neck Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer|
- Response rate [ Time Frame: every 3 month ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: participants will be followed until death ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: participants will be followed until disease progression or death ] [ Designated as safety issue: No ]
- Toxicity profile [ Time Frame: participants will be followed until disease progression or death ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|Experimental: RAD001 group||Drug: everolimus Other: laboratory biomarker analysis|
- To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164176
|Korea, Republic of|
|Hallym University Sacred Heart Hospital|
|Anyang, Gyeonggi-do, Korea, Republic of, 431-070|
|Yeungnam University Medical Center|
|Daegu, Korea, Republic of, 712-749|
|National Cancer Center - Korea|
|Goyang, Korea, Republic of, 410-769|
|Kosin Medical Center Gospel Hospital|
|Pusan, Korea, Republic of, 602-702|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Yonsei Cancer Center at Yonsei University Medical Center|
|Seoul, Korea, Republic of, 120-752|
|Gangnam Severance Hospital|
|Seoul, Korea, Republic of, 135-720|
|Principal Investigator:||Byung Chul Cho||Yonsei University|