Evaluation of Patients With Bulky GIST Using Sunitinib

NCT01054911

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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TumorEvaluation of Patients With Bulky GIST Using Sunitinib
NCT01054911
  1. Birmingham, Alabama
ALL GENDERS
19 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Patients With Bulky GIST Using Sunitinib
Official Title  ICMJE Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tumor
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Sunitinib
  • Procedure: Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 17, 2012)
5
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2010)
12
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01054911
Other Study ID Numbers  ICMJE F090910001
UAB 0855 ( Other Identifier: Institutional study protocol number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party James Posey, MD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:James A. Posey, M.D.University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP