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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 |
Biological: panitumumab |
Phase I |
| 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 | |
| Principal Investigator: | Arie Belldegrun, MD, FACS | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000067539, UCLA-9906078, ABX-EG-9901, UCLA-9906078-04B, NCI-G00-1673 |
| Study First Received: | March 7, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004879 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent renal cell cancer recurrent prostate cancer recurrent colon cancer recurrent rectal cancer |
recurrent non-small cell lung cancer recurrent pancreatic cancer recurrent esophageal cancer |
|
Thoracic Neoplasms Urinary Tract Neoplasm Prostatic Diseases Genital Neoplasms, Male Rectal Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Esophageal Neoplasms Colonic Diseases Urogenital Neoplasms Urologic Neoplasms Rectal Diseases Antibodies, Monoclonal Renal Cancer Respiratory Tract Diseases |
Urologic Diseases Kidney Neoplasms Lung Neoplasms Kidney Diseases Immunoglobulins Endocrine Gland Neoplasms Kidney Cancer Digestive System Neoplasms Rectal Neoplasm Endocrine System Diseases Esophageal Cancer Genital Diseases, Male Intestinal Diseases Recurrence Intestinal Neoplasms |
|
Thoracic Neoplasms Prostatic Diseases Genital Neoplasms, Male Gastrointestinal Diseases Pancreatic Neoplasms Esophageal Neoplasms Colonic Diseases Urogenital Neoplasms Urologic Neoplasms Rectal Diseases Neoplasms by Site Respiratory Tract Diseases Urologic Diseases Lung Neoplasms Kidney Neoplasms |
Kidney Diseases Endocrine Gland Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Digestive System Neoplasms Endocrine System Diseases Genital Diseases, Male Intestinal Diseases Intestinal Neoplasms Carcinoma Neoplasms Digestive System Diseases Lung Diseases Head and Neck Neoplasms Carcinoma, Renal Cell |