Phase I Study of SU5416 in Combination With CPT-11 and Cisplatin in Patients With Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose of SU5416 in combination with irinotecan
and cisplatin in patients with advanced solid tumors. II. Determine the quantitative and
qualitative toxicity of this treatment regimen in terms of organ specificity, time course,
predictability, and reversibility in this patient population. III. Determine the therapeutic
response of this treatment regimen in these patients. IV. Evaluate the clinical
pharmacokinetics and the relationship of kinetics to toxicity and response in this patient
population treated with this regimen.
OUTLINE: This is a dose escalation study of SU5416. Patients receive cisplatin IV over 90
minutes immediately followed by irinotecan IV over 90 minutes and SU5416 IV over 2 hours on
day 1. Patients receive SU5416 alone on day 4. Patients receive combination chemotherapy
weekly for 4 weeks and SU5416 twice weekly for 6 weeks. Courses repeat every 6 weeks 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 reached. The MTD is
defined as the dose preceding that at which 2 of 6 patients experience dose limiting
toxicity.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Eric H. Kraut, MD
Study Chair
Ohio State University Comprehensive Cancer Center
United States: Federal Government
CDR0000068008
NCT00006000
August 2000
March 2004
Name | Location |
---|---|
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |