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

Sponsor

Central European Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00293124

Collaborator

(none)

125

Enrollment

Locations

Duration (Months)

7.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors	Drug: Glivec	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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.

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2008

Outcome Measures

Primary Outcome Measures

Time to Disease Progression [until PD]

Secondary Outcome Measures

Time to Disease Progression [until PD]
Overall Survival [until death]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	AKH, Universitätsklinik für Innere Medizin 1	Vienna	Austria	1090
2	Institute of Oncology Sarajevo	Sarajevo	Bosnia and Herzegovina
3	SBALO National Oncology Center	Sofia	Bulgaria	1527
4	National Oncological Center Hospital	Sofia	Bulgaria
5	Sofia Cancer Center compl. Mladost ,	Sofia	Bulgaria
6	Clinical Hospital Split, Center of Oncology	Split	Croatia
7	University Hospital Rebro	Zagreb	Croatia
8	FN Bulovka	Prague	Czech Republic	186 00
9	Radioterapeticko-onkologicke. Oddeleni FN Motol	Prague	Czech Republic
10	Lithuanian Oncology Center,	Vilnius	Lithuania
11	Institutul Oncologic Bucuresti	Bucuresti	Romania
12	Institutul Oncologic Cluj	Cluj-Napoca	Romania	400015
13	Emergency Clinical County Hospital , Clin Oncol. Dep	Craiova	Romania
14	Institut za onkologiju i	Beograd	Serbia
15	National Institute of Oncology	Bratislava	Slovakia
16	Oncology Institute Ljubljana	Ljubljana	Slovenia