Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: everolimus Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: RAD001 group | Drug: everolimus Other: laboratory biomarker analysis |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Korea, Republic of | |
| Hallym University Sacred Heart Hospital | Recruiting |
| Anyang, Gyeonggi-do, Korea, Republic of, 431-070 | |
| Contact: Contact Person 82-31-380-3704 | |
| Yeungnam University Medical Center | Recruiting |
| Daegu, Korea, Republic of, 712-749 | |
| Contact: Contact Person 82-53-620-4683 | |
| National Cancer Center - Korea | Recruiting |
| Goyang, Korea, Republic of, 410-769 | |
| Contact: Contact Person 82-31-920-1621 | |
| Kosin Medical Center Gospel Hospital | Recruiting |
| Pusan, Korea, Republic of, 602-702 | |
| Contact: Contact Person 82-51-990-6107 | |
| Yonsei Cancer Center at Yonsei University Medical Center | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Contact Person 82-2-2228-8138 cbc1971@yuhs.ac | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Contact Person 82-2-2072-3559 | |
| Gangnam Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 135-720 | |
| Contact: Contact Person 82-2-2019-3297 | |
| Principal Investigator: | Byung Chul Cho | Yonsei University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01164176 History of Changes |
| Other Study ID Numbers: | 4-2009-0542, YONSEI-CRAD001CKR12T, KCSG-HN-10-03 |
| Study First Received: | July 15, 2010 |
| Last Updated: | February 26, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Yonsei University:
|
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 |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Head and Neck Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases Thyroid Diseases Everolimus Sirolimus Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 22, 2013