OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer|
- Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0 [ Designated as safety issue: Yes ]
- Safety profile as measured by CTC v3.0 [ Designated as safety issue: Yes ]
- Response as measured by RECIST every 6 weeks (2 courses) [ Designated as safety issue: No ]
- Pharmacodynamics as measured by drug concentration in the blood during course 1 [ Designated as safety issue: No ]
- Time to progression as measured by Kaplan Meier and RECIST every 6 weeks during treatment and then every 8 weeks [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
- 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.
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Patrick Schoffski, MD, MPH||Hannover Medical School|