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

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293124
• Other study ID #: CECOG/GIST 1.2.001
• Secondary ID: CSTI571BIC07
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2006
• Last updated: August 11, 2015
• Start date: March 2004
• Est. completion date: July 2008

Study information

• Verified date: May 2012
• Source: Central European Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2008
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Central European Cooperative Oncology Group

Countries where clinical trial is conducted

Austria,  Bosnia and Herzegovina,  Bulgaria,  Croatia,  Czech Republic,  Lithuania,  Romania,  Serbia,  Slovakia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Disease Progression		until PD	Yes
Secondary	Time to Disease Progression		until PD	Yes
Secondary	Overall Survival		until death	No

External Links

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