Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer

Phase 1

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00004173
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 1999-12-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2003-07
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Arthur G. James Cancer Hospital - Ohio State University; 🇺🇸 Columbus, Ohio, United States