Protocol Title: Phase III randomised, multi-centre, international trial to determine the relation between dose and clinical activity of STI–571 in patients with unresectable or metastatic malignant gastrointestinal stromal tumors expressing the c–kit receptor tyrosine kinase (CD117).
Study Chair: Professor John Zalcberg (School of Public Health & Preventative Medicine, Monash University, Melbourne VIC)
Associate Oncology Program Manager: Ms Christine Aiken
Trial Coordinator: Ms Christine Aiken
Contact Email: EORTC62005@ctc.usyd.edu.au
Detailed information available on: Australian and New Zealand Clinical Trials Registry — EORTC 62005
Grants Awarded: Novartis Pharmaceuticals Australia P/L, Novartis International AG (Switzerland) and European Organisation for Research and Treatment of Cancer (Belgium)
Aim: To compare the outcome of patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) expressing KIT (CD117) treated with low dose imatinib versus high dose imatinib. Secondary objectives are to assess the response rates of patients treated with these two doses of imatinib and to assess the toxicities of patients in the two treatment groups. Participating research groups have the option to obtain tissue and blood samples from GIST patients before and following treatment with imatinib for future correlative studies. The primary end point of this trial is progression free survival and the secondary endpoints include overall survival, objective response to treatment and toxicity profile. Gastro–intestinal stromal tumours (GIST) are rare and highly resistant to standard chemotherapy and radiation. A new chemotherapy tablet called STI–571 (Glivec ®) has produced dramatic responses in people with this kind of cancer. This trial is comparing higher and lower doses of STI–571 to see which works best. Trials of STI–571 in other cancers are being planned around the world.
Study Design: Phase III Randomised, Multi-centre, International Trial to Determine the Relation between Dose and Clinical Activity of STI571 in Patients with Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing the KIT Receptor Tyrosine Kinase (CD117).
To view study schema click here.