Clinical trial NCT01054911: Evaluation of Patients With Bulky GIST Using Sunitinib
Official title: Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tumor
Keywords: GIST
gastrointestinal stromal tumor
gastrointestinal stomach tumor
Sunitinib
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-01-22
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Measurable Disease Response Rate
timeFrame: FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12
measure: Alteration in Diffusion and Vascularity Kinetics
timeFrame: MRI at baseline, Week 2 and Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: James A. Posey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: