A Phase I Study of SU5416 in Combination With Gemcitabine/Cisplatin in Patients With Advanced Solid Tumors
OBJECTIVES: I. Assess the toxicities and pharmacokinetics of SU5416 when combined with
gemcitabine and cisplatin in patients with advanced solid tumors. II. Determine the
antitumor activity of this combination treatment regimen in this patient population.
OUTLINE: This is an open label, dose escalation study of SU5416. Patients receive
gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour on day 1; SU5416 IV over
70 minutes on day 4; gemcitabine IV over 30 minutes followed by SU5416 IV over 70 minutes on
day 8, and SU5416 on days 11, 15, and 18. Treatment repeats every 3 weeks for a maximum of 6
courses in the absence of disease progression or unacceptable toxicity. Following 6 courses
of therapy, patients with stable and responsive disease may receive SU5416 alone on days 1,
4, 8, 11, 15, and 18 every 3 weeks for a maximum of 1 year. Cohorts of 3-6 patients receive
escalating doses of SU5416 until the maximum tolerated dose (MTD) is reached. The MTD is
defined as the dose preceding that at which at least one third of the patients experience
dose limiting toxicity. Patients are followed at 1 month, and then every 3 months.
PROJECTED ACCRUAL: A total of 16-30 patients will be accrued for this study.
Primary Purpose: Treatment
Lee S. Rosen, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government