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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00293124
First received: February 16, 2006
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: Glivec
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Trial of Glivec in Patients With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing C-kit.

Resource links provided by NLM:


Further study details as provided by Central European Cooperative Oncology Group:

Primary Outcome Measures:
  • Time to Disease Progression [ Time Frame: until PD ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to Disease Progression [ Time Frame: until PD ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: until death ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: until death ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: March 2004
Study Completion Date: July 2008
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Glivec
    400mg p.o./day in a population of patients with locally advanced (=not amenable to surgery with curative intent) or metastatic malignant GIST. Glivec® may be increased to 600 mg p.o./day and then 800 mg p.o./day (400 mg b.i.d.) if the patient is progressing
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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®)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293124

Locations
Austria
AKH, Universitätsklinik für Innere Medizin 1
Vienna, Austria, 1090
Bosnia and Herzegovina
Institute of Oncology Sarajevo
Sarajevo, Bosnia and Herzegovina
Bulgaria
National Oncological Center Hospital
Sofia, Bulgaria
SBALO National Oncology Center
Sofia, Bulgaria, 1527
Sofia Cancer Center compl. Mladost ,
Sofia, Bulgaria
Croatia
Clinical Hospital Split, Center of Oncology
Split, Croatia
University Hospital Rebro
Zagreb, Croatia
Czech Republic
FN Bulovka
Prague, Czech Republic, 186 00
Radioterapeticko-onkologicke. Oddeleni FN Motol
Prague, Czech Republic
Lithuania
Lithuanian Oncology Center,
Vilnius, Lithuania
Romania
Institutul Oncologic Bucuresti
Bucuresti, Romania
Institutul Oncologic Cluj
Cluj-Napoca, Romania, 400015
Emergency Clinical County Hospital , Clin Oncol. Dep
Craiova, Romania
Serbia
Institut za onkologiju i
Beograd, Serbia
Slovakia
National Institute of Oncology
Bratislava, Slovakia
Slovenia
Oncology Institute Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
Central European Cooperative Oncology Group
Investigators
Principal Investigator: Thomas Brodowicz, MD University Clinic of Internal Medicine I / Clinical Oncology
  More Information

Additional Information:
No publications provided

Responsible Party: Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00293124     History of Changes
Other Study ID Numbers: CECOG/GIST 1.2.001, CSTI571BIC07
Study First Received: February 16, 2006
Last Updated: May 15, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Central European Cooperative Oncology Group:
Gastrointestinal Stromal Tumors
Glivec

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on November 19, 2014