NCT00081237

OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer

A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of OSI-7904L and oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer.

Detailed description

OBJECTIVES: Primary * Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with refractory or recurrent advanced colorectal cancer. * Determine the maximum tolerated dose of this regimen in these patients. * Determine a safe dose for this regimen in these patients. Secondary * Determine the pharmacokinetic profile of this regimen in these patients. * Determine the safety profile of this regimen in these patients. * Determine the antitumor activity of this regimen in these patients. OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study. Patients receive oxaliplatin IV over 2 hours followed by OSI-7904L IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of OSI-7904L and oxaliplatin 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 toxicity. A maximum of 12 patients receive treatment at the MTD. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	OSI-7904L
DRUG	oxaliplatin

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-08-01
• First posted: 2004-04-08
• Last updated: 2013-06-12

Locations

2 sites across 2 countries: Germany, United Kingdom