Open-label Trial of GlivecWith Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors

August 11, 2015 updated by: Central European Cooperative Oncology Group

An Open-label Trial of Glivec in Patients With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing C-kit.

The rationale is to assess the clinical and biological activity of Imatinib and to compare the data with historic data.

Additionally this study has been designed to gain more experience with the treatment of GIST in several Central and Eastern European Countries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter open label clinical trial to be performed in patients with incurable malignant GISTs that are unresectable or metastatic. Approximately 150 patients will enter the trial.

Patients will receive Imatinib 400 mg p.o./day for a period of up to 24 months provided that in the opinion of the investigator the patient is benefiting from treatment with Imatinib, and in the absence of any safety concerns.

Treatment after completion of the 24 months study is at the discretion of the investigator. Imatinib should be increased to 600 mg p.o./day and then to 400 mg b.i.d if the patient is progressing on the respective dose level.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • AKH, Universitätsklinik für Innere Medizin 1
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina
        • Institute of Oncology Sarajevo
  • Bulgaria
      • Sofia, Bulgaria, 1527
        • SBALO National Oncology Center
      • Sofia, Bulgaria
        • Sofia Cancer Center compl. Mladost ,
      • Sofia, Bulgaria
        • National Oncological Center Hospital
  • Croatia
      • Split, Croatia
        • Clinical Hospital Split, Center of oncology
      • Zagreb, Croatia
        • University Hospital Rebro
  • Czech Republic
      • Prague, Czech Republic, 186 00
        • FN Bulovka
      • Prague, Czech Republic
        • Radioterapeticko-onkologicke. Oddeleni FN Motol
  • Lithuania
      • Vilnius, Lithuania
        • Lithuanian Oncology Center,
  • Romania
      • Bucuresti, Romania
        • Institutul Oncologic Bucuresti
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic Cluj
      • Craiova, Romania
        • Emergency Clinical County Hospital , Clin Oncol. Dep
  • Serbia
      • Beograd, Serbia
        • Institut za onkologiju i
  • Slovakia
      • Bratislava, Slovakia
        • National Institute of Oncology
  • Slovenia
      • Ljubljana, Slovenia
        • Oncology Institute Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients >= 18 years of age
  • Histologically documented diagnosis of GIST which is malignant as well as unresectable (=not amenable to surgery with curative intent) and/or metastatic and therefore incurable Immunohistochemical documentation of c-kit (CD117) expression by tumor
  • At least one measurable site of disease (as defined by Southwestern Oncology Group Solid Tumor Response Criteria) which has not been previously embolised or irradiated
  • Performance status 0,1, 2 or 3 (ECOG)
  • Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L
  • Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
  • Life expectancy of at least 6 months
  • Written, voluntary, informed consent
  • Patients who were previously treated with chemotherapy will be eligible for this study
  • Patient who are at least 5 years free of melanoma will be eligible for this study

Exclusion Criteria:

  • Patient has received any other investigational agents within 28 days of first day of study drug dosing
  • Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention and CECOGs' approval is obtained, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
  • Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
  • Female patients who are pregnant or breast-feeding.
  • Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
  • Patient has a known brain metastasis
  • Patient has an acute or known chronic liver disease (i.e., chronic active hepatitis, cirrhosis)
  • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection
  • Patient received chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin-C) prior to study entry
  • Patient previously received radiotherapy to >= 25 % of the bone marrow
  • Patient had a major surgery within 2 weeks prior to study entry
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
  • Therapeutic anticoagulation with warfarin (e.g. Coumadin® or Coumadine®)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Disease Progression
Time Frame: until PD
until PD

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Disease Progression
Time Frame: until PD
until PD
Overall Survival
Time Frame: until death
until death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central European Cooperative Oncology Group

Investigators

  • Principal Investigator: Thomas Brodowicz, MD, University Clinic of Internal Medicine I / Clinical Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (Estimate)

February 17, 2006

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CECOG/GIST 1.2.001
  • CSTI571BIC07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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