Evaluation of Patients With Bulky GIST Using Sunitinib

NCT ID: NCT01054911

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sunitinib

Intervention Type: DRUG

All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.

Surgery

Intervention Type: PROCEDURE

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.

Interventions

Sunitinib

All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Other Intervention Names

SUTENT (Sunitinib)

Eligibility Criteria

Inclusion Criteria

• Patients more than 19 years old with pathologically proven GIST which is bulky or marginally resectable
• Patients must have at least one bidimensionally measurable disease site of 5 cm or greater not previously irradiated. Bone lesions do not qualify.
• Patients must have an ECOG performance of greater than or equal to 2, with projected survival of at least three months.
• Patients must have adequate laboratory parameters:

Hematologic: Hb >9.0; WBC >3200 and platelets >100,000/mm3; Hepatic: Bilirubin <2.0 and AST within 4 times upper limit of normal; Renal: Creatinine of less than or equal to 1.6 or eGFR greater than or equal to 50 mL/min

• Men and women who are of childbearing potential must practice strict birth control for the duration of the study.
• Women of childbearing potential must be non-lactating and non-pregnant with a negative pregnancy test within two weeks of trial registration.
• The patient, a witness, and attending physician will have signed an IRB-approved informed consent prior to Sunitinib administration.

Exclusion Criteria

• Known brain metastases or significant pleural effusion or ascites.
• Uncontrolled hypertension, diabetes, or other medical condition.
• Major surgery within 21 days of registration.
• Patients wtih organ grafts with the exception of prior high dose chemotherapy with autologous bone marrow (or stem cell) transplantation.
• History of seizures, central nervous system disorders, dementia, or psychosis that might preclude adequate informed consent or protocol compliance.
• Prior therapy for GIST.
• A history of HIV or hepatitis virus infection.
• Any recent medical condition which, in the opinion of the investigator, makes the patient unsuitable for study participation.
• Patients with impaired kidney function.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

James Posey, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James A. Posey, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB 0855

Identifier Type: OTHER

Identifier Source: secondary_id

F090910001

Identifier Type: -

Identifier Source: org_study_id