Sutent Adjunctive Treatment of Differentiated Thyroid Cancer (IIT Sutent)
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 one year after completing standard therapy. During this time, study participants will be followed closely by their doctor.
Papillary Thyroid Cancer
Follicular Thyroid Cancer
Differentiated Thyroid Cancer
Drug: SU011248, Sutent
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sutent Adjunctive Treatment of Differentiated Thyroid Cancer|
- The primary objective is to assess clinical benefit rate, defined as complete response, partial response, or stable disease per RECIST criteria. [ Time Frame: 12 months after last patient completes treatment ] [ Designated as safety issue: No ]
- The secondary objective will be to assess the safety of Sutent in this patient population. [ Time Frame: quarterly ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm - Sutent
Sutent 37.5 mg/day will be given orally.
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.
Other Name: Sunitinib
This is a two-stage, phase II with historical controls, 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 in comparison to historical controls. 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.
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Kenneth D Burman, MD||Washington Hospital Center|