Status:
COMPLETED
Prospective Multicentric Randomized Study of Glivec® in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Sarcoma
Gastro-intestinal Stromal Tumors (GIST)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GIST...
Detailed Description
Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. GIST cells are positive for ...
Eligibility Criteria
Inclusion
- Patients 18 years of age or over.
- Histologically documented diagnosis of malignant GIST.
- Immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases using the DAKO assay.
- Performance status 0,1, 2, 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 \> 1.0 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. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 2 weeks (according to updated Invest. Brochure) following discontinuation of study drug.
- Written, voluntary, informed consent.
Exclusion
- Patient has another malignant tumor in CR\<3 years (except if the other primary malignancy is inactive and not requiring active intervention). Previous basal cell skin cancer or a cervical carcinoma in situ are 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 known diagnosis of human immunodeficiency virus (HIV) infection.
- Patients received chemotherapy within 2 weeks prior to study entry, unless the disease is rapidly progressing
- Patients had a major surgery within 2 weeks prior to entry study
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- Previous treatment with Glivec®
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT00367861
Start Date
May 1 2002
End Date
May 1 2013
Last Update
February 24 2014
Active Locations (8)
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1
Institut Bergonié
Bordeaux, France, 33000
2
Centre Oscar Lambret
Lille, France, 59000
3
Centre Leon Berard
Lyon, France, 69008
4
Hopital Edouard Herriot
Lyon, France, 69008