A Phase I Study of Oxaliplatin in Combination With Paclitaxel
- Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with
metastatic or unresectable cancer.
- Determine the qualitative and quantitative toxicities of this regimen in these
- Determine the therapeutic response to this regimen in these patients.
- Determine the relationship between the pharmacokinetics of this regimen and toxicity
and response in these patients.
- Determine the effects of oxaliplatin on peripheral blood cells and correlate this to
pharmacokinetics, toxicity, and response in these patients.
OUTLINE: This is a dose escalation study.
Patients receive oxaliplatin IV over 2 hours followed by paclitaxel IV over 1 hour weekly
for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and paclitaxel until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more
than 1 of 6 patients experiences dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12-18
Primary Purpose: Treatment
Eric H. Kraut, MD
Ohio State University Comprehensive Cancer Center
United States: Federal Government
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|