An Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small-Cell Lung, Colorectal, or Esophageal Cancer
- Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate,
pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction
- Determine the pharmacokinetics and the dose-response relationship of this drug in this
- Evaluate the clinical effect of this drug in this patient population.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3*
(enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of
patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks
on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing
full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on
NOTE: *All patients receive a total of 4 doses.
Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 or 3 patients experience dose-limiting toxicity.
Patients are followed every 2 weeks for 5 weeks.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within
approximately 14 months.
Masking: Open Label, Primary Purpose: Treatment
Arie Belldegrun, MD, FACS
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|