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| Sponsor: | 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 - At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Symptomatic brain metastases requiring treatment - Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis - Use of systemic chemotherapy or radiotherapy within 30 days before enrollment - Prior epidermal growth factor receptor targeting agents - Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins with longer serum half-life (e.g., AvastinTM) within 6 weeks before enrollment
Contacts and Locations
Hide Study Locations| United States, Alabama | |
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| Muscle Shoals, Alabama, United States | |
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| Birmingham, Alabama, United States | |
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| Bessemer, Alabama, United States | |
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| Racine, Wisconsin, United States | |
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| Glendale, Wisconsin, United States | |
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| Madison, Wisconsin, United States | |
| Study Director: | MD | Amgen |
More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20030167 |
| Study First Received: | May 26, 2004 |
| Last Updated: | November 19, 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 |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Irinotecan Colonic Diseases Enzyme Inhibitors 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 Antineoplastic Agents, Phytogenic Colorectal Neoplasms |