NCT00668811

Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed. This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates. By entering into this study, participants agree to take oral Sutent for approximately two years after completing standard therapy. During this time, study participants will be followed closely by their doctor.

Detailed description

This is a two-stage, phase II, single center, targeted therapy trial enrolling patients with stage 2 (for patients younger than 45 years of age), 3 or 4 differentiated thyroid cancer. The primary objective is to assess progression free survival in this population. Sutent will be given orally at 37.5mg daily for two (2) year, or 26 cycles. Each treatment cycle will consist of 28 days. Upon treatment discontinuation, patients will be followed for survival. The frequency and type of survival follow-up assessments performed will be at the discretion of the treating physician.

Conditions

• Papillary Thyroid Cancer
• Follicular Thyroid Cancer
• Differentiated Thyroid Cancer

Interventions

Type	Name	Description
DRUG	SU011248, Sutent	Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.

Timeline

• Start date: 2008-04-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2008-04-29
• Last updated: 2020-08-05
• Results posted: 2018-04-18

Locations

1 site across 1 country: United States