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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00559949 |
RATIONALE: AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well AZD6244 works in treating patients with papillary thyroid cancer that did not respond to radioactive iodine.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: MEK inhibitor AZD6244 Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase 2 Study of AZD6244 in Iodine-131 Refractory Papillary Thyroid Carcinoma and Papillary Thyroid Carcinoma With Follicular Elements |
Estimated Enrollment: | 32 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral AZD6244 twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.
Archived tissue is examined for gene mutations, including RET, BRAF, NTRK, and RAS, by fluorescence in situ hybridization and/or polymerase chain reaction and fluorescence melting curve analysis. Protein expression of ERK and phosphorylated ERK is assessed by immunohistochemical staining.
Blood samples are collected periodically for pharmacokinetic analysis and biomarker assessment (thyroglobulin and antithyroglobulin autoantibodies).
After completion of study therapy, patients are followed periodically for up to 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No longer amenable to radioactive iodine therapy or curative surgical resection
Evidence of disease progression (objective growth of existing tumors)
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
Tampa, Florida, United States, 33612-9497 | |
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
United States, Illinois | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19111-2497 | |
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6307 | |
Contact: Christine Chung, MD 615-322-4967 |
Study Chair: | D. Neil Hayes | UNC Lineberger Comprehensive Cancer Center |
Responsible Party: | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill ( Lisa A. Carey ) |
Study ID Numbers: | CDR0000574262, MCC-15305, MCC-LOI-7918 |
Study First Received: | November 16, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00559949 History of Changes |
Health Authority: | Unspecified |
stage I papillary thyroid cancer stage II papillary thyroid cancer stage III papillary thyroid cancer stage IV papillary thyroid cancer recurrent thyroid cancer |
Thyroid Neoplasms Thyroid Cancer, Papillary Head and Neck Neoplasms Iodine Endocrine System Diseases |
Endocrinopathy Thyroid Diseases Recurrence Endocrine Gland Neoplasms Carcinoma |
Neoplasms Neoplasms by Site Thyroid Neoplasms Head and Neck Neoplasms |
Endocrine System Diseases Thyroid Diseases Endocrine Gland Neoplasms |