Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of docetaxel and oxaliplatin in treating patients who have metastatic or recurrent solid tumor.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: docetaxel Drug: oxaliplatin||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Oxaliplatin in Combination With Docetaxel (Taxotere) Metastatic/Recurrent Solid Tumors|
|Study Start Date:||March 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004243
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|Beckman Research Institute, City of Hope|
|Los Angeles, California, United States, 91010|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Study Chair:||Heinz-Josef Lenz, MD||University of Southern California|