Dose Finding and Phase II Study of STI 571 in Advanced Soft Tissue Sarcoma
OBJECTIVES: I. Determine the maximum tolerated dose and associated toxicity of STI571 in
patients with refractory or recurrent soft tissue sarcoma. II. Determine the pharmacokinetic
profile of this treatment regimen in these patients. III. Determine the objective response
and duration of response in these patients with this treatment regimen.
OUTLINE: This is a dose escalation and dose efficacy, multicenter study. In the dose
efficacy portion, patients are stratified according to disease type (gastrointestinal
stromal tumor vs all other soft tissue sarcomas). Phase I: Patients receive oral STI571
daily for a maximum of 24 months in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-8 patients receive escalating doses of STI571 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6-8
patients experience dose limiting toxicities. The recommended phase II dose is defined as
the dose preceding the MTD. Phase II: Patients receive the recommended phase II dose of
STI571 as in phase I. Patients are followed every 8 weeks until disease progression, and
then every 16 weeks thereafter.
PROJECTED ACCRUAL: Approximately 47-72 patients (7-32 in phase I and 40 in phase II) will be
accrued for this study.
Primary Purpose: Treatment
Jacob Verweij, MD, PhD
Daniel Den Hoed Cancer Center at Erasmus Medical Center
United States: Federal Government