Clinical Trial: Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
Brief 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 one year after completing standard therapy. During this time, study participants will be followed closely by their doctor.
Detailed Summary: 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.
Sponsor: Washington Hospital Center
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: The secondary objective will be to assess the safety of Sutent in this patient population. [ Time Frame: quarterly ]
Original Secondary Outcome: Same as current
Information By: Washington Hospital Center
Dates:
Date Received: April 25, 2008
Date Started: April 2008
Date Completion:
Last Updated: March 24, 2016
Last Verified: March 2016
