SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00006257
- Lead Sponsor
- City of Hope Medical Center
- Brief Summary
RATIONALE: Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and paclitaxel in treating patients who have advanced cancer.
- Detailed Description
OBJECTIVES:
* 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 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Cancer Center and Beckman Research Institute, City of Hope🇺🇸Duarte, California, United States