Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Leiden University Medical Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01118065
First received: May 5, 2010
Last updated: May 12, 2010
Last verified: May 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 progressive or recurrent, unresectable, or metastatic thyroid cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: everolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study to Investigate the Efficacy of RAD001 (Afinitor®, Everolimus) in Patients With Irresectable Recurrent or Metastatic Differentiated, Undifferentiated (Anaplastic) and Medullary Thyroid Carcinoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Efficacy [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maximum percentage of tumor reduction [ Designated as safety issue: No ]
- Activity time to event endpoints [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 42 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.
Secondary
- To determine maximum percentage of tumor reduction in these patients.
- To describe activity time to event endpoints.
- To assess toxicity.
- To determine evolution of serum thyroglobulin.
- To perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory)
- To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer.
OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria:
- Progressive or recurrent disease
- Metastatic disease
- Unresectable disease
Meeting any of the following thyroid cancer subtypes:
- Differentiated thyroid cancer (i.e., papillary, follicular, or Hurthle cell disease) that is radio-iodine refractory
- Undifferentiated thyroid cancer (i.e., anaplastic disease)
- Medullary thyroid cancer
- Must have received prior everolimus or other mTOR inhibitor therapy
- Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed
PATIENT CHARACTERISTICS:
- Karnofsky performance score 70-100%
- ANC ≥ 1,500/mm^³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 5.6 mmol/L
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for known liver metastases)
- Serum creatinine ≤ 2 times ULN
- Negative pregnancy test
- No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118065
Locations
| Netherlands | |
| Leiden University Medical Center | Recruiting |
| Leiden, Netherlands, 2300 RC | |
| Contact: Contact Person 31-71-526-3486 h.w.kapiteijn@lumc.nl | |
Sponsors and Collaborators
Leiden University Medical Center
Investigators
| Principal Investigator: | Ellen Kapiteijn, MD, PhD | Leiden University Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01118065 History of Changes |
| Other Study ID Numbers: | CDR0000672171, DUT-LUMC-CRAD001CNL08T, EUDRACT-2009-016669-27, EU-21037, NL-31245-058-10 |
| Study First Received: | May 5, 2010 |
| Last Updated: | May 12, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
anaplastic 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 19, 2013