Evaluation of Patients With Bulky GIST Using Sunitinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01054911
Recruitment Status : Terminated (poor accrual)
First Posted : January 22, 2010
Results First Posted : June 3, 2016
Last Update Posted : September 22, 2016
Information provided by (Responsible Party):
James Posey, MD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Tumor Drug: Sunitinib Procedure: Surgery Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST
Study Start Date : October 2009
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2015

Arm Intervention/treatment
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.
Drug: Sunitinib
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.

Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Measurable Disease Response Rate [ Time Frame: FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12 ]
    Positron electron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) and computed tomography (CT) will be used. None of the participants were analyzed

  2. Alteration in Diffusion and Vascularity Kinetics [ Time Frame: MRI at baseline, Week 2 and Week 6 ]
    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.

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01054911

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: James A. Posey, M.D. University of Alabama at Birmingham

Responsible Party: James Posey, MD, Associate Professor, University of Alabama at Birmingham Identifier: NCT01054911     History of Changes
Other Study ID Numbers: F090910001
UAB 0855 ( Other Identifier: Institutional study protocol number )
First Posted: January 22, 2010    Key Record Dates
Results First Posted: June 3, 2016
Last Update Posted: September 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by James Posey, MD, University of Alabama at Birmingham:
gastrointestinal stromal tumor
gastrointestinal stomach tumor

Additional relevant MeSH terms:
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors