Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies
- Determine the maximum tolerated dose of SU5416 when combined with paclitaxel in
patients with advanced malignancies.
- Determine the toxicities and pharmacokinetics of this regimen in these patients.
- Determine the effects of this regimen on a variety of histological and molecular
biomarkers of angiogenesis, including in vitro activity assays of endothelial cell
proliferation, migration, and invasion.
OUTLINE: This is a dose escalation study of SU5416.
Patients receive SU5416 IV over 1 hour twice weekly during the first week. During subsequent
courses, SU5416 is administered on days 1, 4, 8, 11, 15, 18, 22, and 25. Paclitaxel begins
on the second week of therapy and is administered IV over 1 hour on days 1, 8, 15, and 22.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 12-18
Primary Purpose: Treatment
Przemyslaw W. Twardowski, MD
Beckman Research Institute
United States: Federal Government
|Cancer Center and Beckman Research Institute, City of Hope||Duarte, California 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|University of California Davis Cancer Center||Sacramento, California 95817|