NCT00004879

Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.

Detailed description

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.

Conditions

• Colorectal Cancer
• Esophageal Cancer
• Kidney Cancer
• Lung Cancer
• Pancreatic Cancer
• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	panitumumab

Timeline

• Start date: 2000-04-01
• Primary completion: 2005-07-01
• First posted: 2003-01-27
• Last updated: 2013-01-08

Locations

2 sites across 1 country: United States