Iodine I 131 and Pazopanib Hydrochloride in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer Previously Treated With Iodine I 131 That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT01413113|
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : November 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent 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||Drug: pazopanib hydrochloride Radiation: iodine I 131||Phase 1|
I. To determine the safety, tolerability and feasibility of administrating escalating doses of 131I (iodine I 131) in combination with concurrent pazopanib (pazopanib hydrochloride) therapy in order to define the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) in patients with radioiodine (RAI)-refractory disease with minor RAI-uptake.
I. To determine the effects of pazopanib in combination with 131I on RAI-avidity, uptake and tumor response rate (Response Evaluation Criteria In Solid Tumors [RECIST] version 1.1).
II. To determine the time to tumor progression (TTP) or recurrence (progression will be determined by RECIST criteria and by increases in suppressed thyroglobulin levels > 50% as compared to tumor imaging and suppressed thyroglobulin levels performed within 1 week of the last dose of pazopanib).
OUTLINE: This is a dose-escalation study of iodine I 131.
Patients receive iodine I 131 intramuscularly (IM) once daily (QD) 5 days a week in weeks 5-6. Patients also receive pazopanib hydrochloride orally (PO) QD beginning in week 1 and continuing for 8 weeks post-radioactive iodine therapy.
After completion of study treatment, patients are followed up at 28 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Trial of Pazopanib in Combination With Escalating Doses of Radioactive 131I in Patients With Well-Differentiated Thyroid Carcinoma Refractory to Radioiodine, Despite Having Some Uptake|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||October 2015|
Experimental: Treatment (enzyme inhibitor and radioactive drug therapy)
Patients receive iodine I 131 IM QD 5 days a week in weeks 5-6. Patients also receive pazopanib hydrochloride PO QD beginning in week 1 and continuing for 8 weeks post-radioactive iodine therapy.
Drug: pazopanib hydrochloride
Other Names:Radiation: iodine I 131
- Toxicity and the occurrence of dose limiting toxicity (DLT) when pazopanib is given in conjunction with radioiodine to establish the MTD and RP2D in combination [ Time Frame: 8 weeks post radioactive iodine administration ]Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.03), timing, seriousness, and relatedness; and laboratory abnormalities. Descriptive statistics will be calculated for all variables and responses; continuous data will be expressed as their mean +/- standard deviation, median and range, and categorical data will be listed by frequency of occurrence and proportion of total (with 95% confidence intervals) for all enrolled patients and by dose cohort.
- Tumor response [ Time Frame: At week 14 ]Assessed using RECIST criteria. Tumor response will be compared to responses and duration of TTP after last prior historical RAI treatment.
- TTP [ Time Frame: At week 14 ]TTP will be compared to responses and duration of TTP after last prior historical RAI treatment.
- Increased radioiodine uptake, retention and correlative effects of pazopanib on tumor blood flow and response in WDTC (assessed by dynamic FDG-PET) [ Time Frame: At 14 week ]Will be predominantly descriptive with graphical information where available.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413113
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Laura Chow||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|