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| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004879 |
Purpose
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.
| Condition | Intervention | Phase |
|
Colorectal Cancer Esophageal Cancer Kidney Cancer Lung Cancer Pancreatic Cancer Prostate Cancer |
Drug: panitumumab |
Phase I |
| MedlinePlus related topics: | Cancer Colorectal Cancer Esophageal Cancer Esophagus Disorders Kidney Cancer Lung Cancer Pancreatic Cancer Prostate Cancer |
| ChemIDplus related topics: | Panitumumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | 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 |
| Study Start Date: | April 2000 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Renal cell cancer (RCC)
Prostate cancer
Pancreatic cancer
Non-small cell lung cancer
Colorectal cancer
Esophageal cancer
Epidermal growth factor receptor overexpression
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |||||
| Jonsson Comprehensive Cancer Center, UCLA | |||||
| Los Angeles, California, United States, 90095-1738 | |||||
| United States, Pennsylvania | |||||
| Fox Chase Cancer Center | |||||
| Philadelphia, Pennsylvania, United States, 19111 | |||||
| Jonsson Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Arie Belldegrun, MD, FACS | Jonsson Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067539, UCLA-9906078, ABX-EG-9901, UCLA-9906078-04B, NCI-G00-1673 |
| First Received: | March 7, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004879 |
| Health Authority: | United States: Federal Government |
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