Evaluation of Patients With Bulky GIST Using Sunitinib
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST|
- Safety/Adverse Event Outcome Measure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Measurable Disease Response Rate [ Time Frame: FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12 ] [ Designated as safety issue: No ]Positron electron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) and computed tomography (CT) will be used. None of the participants were analyzed
- Alteration in Diffusion and Vascularity Kinetics [ Time Frame: MRI at baseline, Week 2 and Week 6 ] [ Designated as safety issue: No ]The Response Evaluation Criteria in Solid Tumors (RECIST) criteria may be insensitive in assessing GIST so the Choi criteria will be used. The Choi criteria accounts for morphologic tumor changes and biologic alterations. Diffusion-weighted magnetic resonance imaging (MRI) and dynamic contrast magnetic resonance will be used to find the vascular permeability and apparent diffusion coefficient 9ACD) at baseline, Week 2 and Week 6. Weeks 2 and 6 values will be compared to the baseline values using paired t tests.
|Study Start Date:||October 2009|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Sunitinib pill
Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
Other Name: SUTENT (Sunitinib)Procedure: Surgery
Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.
Gastrointestinal stromal tumor (GIST) is a rare cancer affecting primarily the digestive tract and sometimes abdominal cavity in adults. The most common site is the stomach followed by the duodenum and small intestine.
Surgery is the mainstay of therapy for GIST patients whose primary tumor is felt to be resectable. Prior to the introduction of Gleevec, patients with inoperable GIST had essentially no therapeutic options. However, sunitinib trials offer options to patients who are Gleevec resistant or have intolerant GIST. Clinical benefit has been demonstrated with positive results in several sunitinib studies of varying phases.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054911
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||James A. Posey, M.D.||University of Alabama at Birmingham|