NCT00006000

SU5416, Irinotecan, and Cisplatin in Treating Patients With Advanced Solid Tumors

Phase I Study of SU5416 in Combination With CPT-11 and Cisplatin in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SU5416 may stop the growth of solid tumors by stopping blood flow to the tumor. Combining SU5416 with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of SU5416 plus irinotecan and cisplatin in treating patients who have advanced solid tumors.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	irinotecan hydrochloride
DRUG	semaxanib

Timeline

• Start date: 2000-08-01
• Completion: 2004-03-01
• First posted: 2004-03-05
• Last updated: 2013-01-31

Locations

1 site across 1 country: United States