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Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST

19 Years
Open (Enrolling)

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Trial Information

Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To characterize the safety/tolerability of sunitinib given neoadjuvantly.

Outcome Time Frame:

~24 months

Safety Issue:


Principal Investigator

James A. Posey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:




Start Date:

October 2009

Completion Date:

May 2013

Related Keywords:

  • Tumor
  • GIST
  • gastrointestinal stromal tumor
  • gastrointestinal stomach tumor
  • Sunitinib



University of Alabama at BirminghamBirmingham, Alabama  35294-3300