NCT01413113

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of iodine I 131 when given together with pazopanib hydrochloride in treating patients with recurrent and/or metastatic thyroid cancer previously treated with iodine I 131 that cannot be removed by surgery. Radioactive drugs, such as iodine I 131, may carry radiation directly to cancer cells and not harm normal cells. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iodine I 131 together with pazopanib hydrochloride may be an effective treatment for thyroid cancer.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	pazopanib hydrochloride	Given PO
RADIATION	iodine I 131	Given IM

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-11-01
• Completion: 2015-10-01
• First posted: 2011-08-10
• Last updated: 2015-11-05

Locations

1 site across 1 country: United States