A Phase I Study of Oxaliplatin in Combination With Docetaxel (Taxotere) Metastatic/Recurrent Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel when followed by
oxaliplatin in patients with metastatic or recurrent solid tumors. II. Describe the
toxicities of this regimen in this patient population at each dose level studied. III.
Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients.
OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1
hour followed by oxaliplatin IV over 2 hours on day 1 every 3 weeks. Treatment continues in
the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive
escalating doses of docetaxel 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
toxicities. Patients are followed for disease progression.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Heinz-Josef Lenz, MD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|
|Beckman Research Institute, City of Hope||Los Angeles, California 91010|
|University of California Davis Cancer Center||Sacramento, California 95817|