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| Sponsored by: |
Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00083616 |
Purpose
The purpose of this study is to determine that ABX-EGF will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Drug: ABX-EGF |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy |
| Estimated Enrollment: | 185 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Open label, single arm: Experimental
Panitumumab 6 mg/kg every 2 weeks
|
Drug: ABX-EGF
Panitumumab 6 mg/kg every 2 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy) - Metastatic colorectal carcinoma - Eastern Cooperative Oncology Group of 0, 1 or 2 - Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer - Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required - Bidimensionally measurable disease - Tumor expressing EGFr by immunohistochemistry
Contacts and Locations
More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20030167 |
| Study First Received: | May 26, 2004 |
| Last Updated: | January 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00083616 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
EGFr Clinical Trial Panitumumab ABX-EGF |
Immunex Amgen Abgenix Metastatic Cancer |
|
Oxaliplatin Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases |
Neoplasm Metastasis Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
|
Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Oxaliplatin |
Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site Digestive System Diseases Therapeutic Uses Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |