Sunitinib in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
This phase II trial is studying the side effects and how well sunitinib works in treating patients with thyroid cancer that did not respond to iodine I 131 (radioactive iodine) and cannot be removed by surgery. Sunitinib 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
Papillary Thyroid Cancer
Recurrent Thyroid Cancer
Stage III Follicular Thyroid Cancer
Stage IVA Follicular Thyroid Cancer
Stage IVA Papillary Thyroid Cancer
Stage IVB Follicular Thyroid Cancer
Stage IVB Papillary Thyroid Cancer
Stage IVC Follicular Thyroid Cancer
Stage IVC Papillary Thyroid Cancer
Thyroid Gland Medullary Carcinoma
Drug: sunitinib malate
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Sunitinib (SU11248) in Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers and Medullary Thyroid Cancers|
- Objective response rate [ Time Frame: Every 12 weeks, assessed up to 2 years ] [ Designated as safety issue: No ]Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) if measurable disease is present or by a 50% decrease in the respective serum marker (thyroglobulin in cohort A and calcitonin in cohort B documented on at least 2 occasions, at least 4 weeks apart). All of the patients who met the eligibility criteria (with the possible exception of those who received no study medication) will be included in the main analysis of the response rate.
- Toxicity [ Time Frame: From time of first treatment with sunitinib, assessed up to 2 years ] [ Designated as safety issue: Yes ]All adverse events should be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Due to the small sample size and absence of high quality historic data for this disease, these analyses will be mostly exploratory and descriptive in nature.
- Time to progression [ Time Frame: Time from start of treatment to time of progression or death of any cause, assessed up to 2 year ] [ Designated as safety issue: No ]Progression will be evaluated in this study using the new international criteria proposed by RECIST Committee. Due to the small sample size and absence of high quality historic data for this disease, these analyses will be mostly exploratory and descriptive in nature. Kaplan-Meier (1958) curves will be generated and 90% confidence intervals (Brookmeyer and Crowley, 1982) will be derived for median progression-free.
- Overall survival [ Time Frame: Assessed up to 2 years ] [ Designated as safety issue: No ]Due to the small sample size and absence of high quality historic data for this disease, these analyses will be mostly exploratory and descriptive in nature. Kaplan-Meier (1958) curves will be generated and 90% confidence intervals (Brookmeyer and Crowley, 1982) will be derived for median overall survival.
|Study Start Date:||August 2006|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (kinase inhibitor therapy)
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Drug: sunitinib malate
Other Names:Other: laboratory biomarker analysis
Optional correlative studiesOther: pharmacogenomic studies
Optional correlative studies
Other Name: Pharmacogenomic Study
I. Determine the response rate to sunitinib (sunitinib malate) in patients with iodine-refractory, unresectable well-differentiated thyroid cancer (WDCT) or medullary thyroid cancer (MTC) who have evidence of disease progression within the past 6 months.
II. Determine the toxicity of this drug in these patients. III. Determine the duration of response, progression-free survival, and overall survival of patients with WDTC or MTC treated with this drug.
IV. Determine whether the presence of RET gene rearrangements in patients with WDTC or RET mutations in patients with MTC predict response to sunitinib.
V. Determine whether therapy with sunitinib affects phosphorylation of downstream RET effector, ERK, in WDTC and MTC tissue.
VI. Determine whether specific germ-line polymorphisms in the RET gene are associated with favorable outcome in patients with WDTC treated with sunitinib.
OUTLINE: This is an open-label, parallel-group, cohort, multicenter study. Patients are assigned to 1 of 2 cohorts according to type of thyroid cancer (medullary vs well-differentiated).
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ezra Cohen||University of Chicago Comprehensive Cancer Center|