Evaluation of Patients With Bulky GIST Using Sunitinib

NCT01054911 | Terminated Results DMC

• 2 other identifiers: F090910001UAB 0855
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor

Keywords

GIST; gastrointestinal stromal tumor; gastrointestinal stomach tumor; Sunitinib

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  6 months

Secondary Outcomes (2)

• Measurable Disease Response Rate

  FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12

• Alteration in Diffusion and Vascularity Kinetics

  MRI at baseline, Week 2 and Week 6

Study Arms (1)

Sunitinib pill

EXPERIMENTAL

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; Procedure: Surgery

Interventions

Sunitinib DRUG

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

Also known as: SUTENT (Sunitinib)

Sunitinib pill

Surgery 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.

Sunitinib pill

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Pfizer: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Neoplasms; Gastrointestinal Stromal Tumors

Interventions

Sunitinib; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

This Pilot trial was terminated early due sluggish accrual; thereby, resulting in much smaller numbers.

Results Point of Contact

• Title: Dr. James Posey, MD
• Organization: University of Alabama in Birmingham, Comprehensive Cancer Center

jposey@uabmc.edu

205-934-0916

Study Officials

• James A. Posey, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 22, 2010
• Study Start: October 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: September 22, 2016
• Results First Posted: June 3, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)