A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0
Patrick Schoffski, MD, MPH
Hannover Medical School
United States: Federal Government