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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 |
| MedlinePlus related topics: | Cancer Colorectal Cancer |
| Drug Information available for: | Irinotecan Irinotecan hydrochloride Oxaliplatin Panitumumab |
| 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
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Drug: ABX-EGF
Panitumumab 6 mg/kg every 2 weeks
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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 More Information
AmgenTrials clinical trials website
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| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20030167 |
| First Received: | May 26, 2004 |
| Last Updated: | March 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00083616 |
| Health Authority: | United States: Food and Drug Administration |
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