Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004879
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2000-03-07
Brief Title:
Monoclonal Antibody ABX-EGF in Treating Patients With Renal Kidney Prostate Pancreatic Non-Small Cell Lung Colon or Rectal Esophageal or Gastroesophageal Junction Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 42103 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
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 42103 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1673 | None | None | None |
| UCLA-9906078 | None | None | None |
| ABX-EG-9901 | None | None | None |
| UCLA-9906078-04B | None | None | None |