Evaluation of Patients With Bulky GIST Using Sunitinib - Full Text View

Sponsor:	University of Alabama at Birmingham
Collaborator:	Pfizer
Information provided by (Responsible Party):	James Posey, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT01054911

Purpose

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	Intervention	Phase
Tumor	Drug: Sunitinib Procedure: Surgery	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

To characterize the safety/tolerability of sunitinib given neoadjuvantly. [ Time Frame: ~24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the degree of alteration in diffusion and vascular kinetics in GIST tumors receiving sunitinib therapy. [ Time Frame: ~24 months ] [ Designated as safety issue: No ]
To describe any evidence of anti-tumor efficacy and correlate it with any alteration of vascular kinetics/diffusion and cKIT or PDGFr mutation. [ Time Frame: ~24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054911

Contacts

Contact: Dayle Craig, RN	205-975-8080	Dayle.Craig@ccc.uab.edu
Contact: Alma DelGrosso, RN, BSN, OCN	205-934-0337	Alma.DelGrosso@ccc.uab.edu

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

Pfizer

Investigators

Principal Investigator:

James A. Posey, M.D.

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	James Posey, MD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT01054911 History of Changes
Other Study ID Numbers:	F090910001, UAB 0855
Study First Received:	January 20, 2010
Last Updated:	January 24, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

GIST
gastrointestinal stromal tumor
gastrointestinal stomach tumor
Sunitinib

Additional relevant MeSH terms:

Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors

Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012