Status: Closed
Activation Date: 2001JAN10
Closing Date: 2001SEP01
Phase: III
Description: Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)
Eligibility: Patients must have a biopsy proven diagnosis of gastrointestinal stromal tumour (GIST) which is distantly metastatic or unresectable. The primary must be of visceral or intraabdominal origin. All patients must have immunohistochemical documentation of KIT (CD117) expression by tumour documented by DAKO antibody staining. Patients must have an identified team (including a medical oncologist and a surgeon) to provide care.
Objective: To compare overall and progression-free survival for patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) expressing KIT (CD 117) treated with low dose STI-571 versus high dose STI-571. To assess response rates (confirmed, unconfirmed, complete and partial) and toxicities of patients treated with these two doses of STI-571. To obtain tissue and blood samples from GIST patients before and following treatment with STI-571 for future correlative studies.
Participation: Open to member centres
Lay Description: The purpose of this study is to evaluate whether an investigational drug called STI571 might be effective in patients with malignant GIST. At this time, it is not known if this medicine will work against this type of cancer, however laboratory experiments and limited clinical experience in patients with GIST suggest that STI571 may be able to inhibit the growth of GIST cells.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| SARCOMA | SR4 | 49 | 1 | 0 | 1 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| SARCOMA | SR4 | 49 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| SARCOMA | SR4 | 49 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |