NCT00004173

Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer

A Phase I Study of Oxaliplatin in Combination With Paclitaxel

• Status: Unknown
• 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating patients who have metastatic or unresectable cancer.

Detailed description

OBJECTIVES: * 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 patients. * 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 unacceptable toxicity. 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 months.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	oxaliplatin
DRUG	paclitaxel

Timeline

• Start date: 1999-10-01
• First posted: 2003-01-27
• Last updated: 2013-05-15

Locations

1 site across 1 country: United States