Sutent Adjunctive Treatment of Differentiated Thyroid Cancer (IIT Sutent)
|ClinicalTrials.gov Identifier: NCT00668811|
Recruitment Status : Completed
First Posted : April 29, 2008
Results First Posted : April 18, 2018
Last Update Posted : June 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Papillary Thyroid Cancer Follicular Thyroid Cancer Differentiated Thyroid Cancer||Drug: SU011248, Sutent||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sutent Adjunctive Treatment of Differentiated Thyroid Cancer|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2015|
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
- Progression Free Survival [ Time Frame: 12 months after last patient completes treatment ]Progressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- Overall Survival [ Time Frame: 12 months after last patient completes treatment ]Overall survival is defined as the time from the start of treatment to the time to death from any cause or final data collection, whatever happens first.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668811
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Kenneth D Burman, MD||Washington Hospital Center|