Prospective Multicentric Randomized Study of Glivec® in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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 GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Collaborator: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

1. Patients 18 years of age or over.

2. Histologically documented diagnosis of malignant GIST.

3. Immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases using the DAKO assay.

4. Performance status 0,1, 2, 3 (ECOG)

5. 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.

6. 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.

7. Written, voluntary, informed consent.

Exclusion Criteria:

1. 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.

2. 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)

3. Female patients who are pregnant or breast-feeding.

4. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.

5. Patients received chemotherapy within 2 weeks prior to study entry, unless the disease is rapidly progressing

6. Patients had a major surgery within 2 weeks prior to entry study

7. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

8. Previous treatment with Glivec®