Finding studies
Finding studies
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Lead
Jonsson Comprehensive Cancer Center
With
OBJECTIVES: * Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer. * Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population. * 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 weeks 3-5. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
