NCT01054911

Evaluation of Patients With Bulky GIST Using Sunitinib

Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.

Detailed description

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.

Conditions

• Tumor

Interventions

Type	Name	Description
DRUG	Sunitinib	All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2014-09-01
• Completion: 2015-09-01
• First posted: 2010-01-22
• Last updated: 2016-09-22
• Results posted: 2016-06-03

Locations

1 site across 1 country: United States