Evaluating ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy - Tabular View

Tracking Information

First Received Date ^ICMJE

May 26, 2004

Last Updated Date

November 19, 2009

Start Date ^ICMJE

March 2004

Estimated Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Confirmed objective response through week 16 [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Confirmed objective response through week 16
Duration of response

Change History

Complete list of historical versions of study NCT00083616 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Confirmed objective response throughout study [ Designated as safety issue: No ]
Time to response [ Designated as safety issue: No ]
Progression-free survival time [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]
Time to treatment failure [ Designated as safety issue: No ]
Duration of stable disease [ Designated as safety issue: No ]
Survival time [ Designated as safety issue: No ]
Change in patient-reported outcomes [ Designated as safety issue: No ]
Safety [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Confirmed objective response throughout study
Time to response
Progression-free survival time
Time to disease progression
Time to treatment failure
Duration of stable disease
Survival time
Change in patient-reported outcomes
Safety

Descriptive Information

Brief Title ^ICMJE

Evaluating ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Colorectal Cancer
Metastatic Cancer

Intervention ^ICMJE

Drug: ABX-EGF

Study Arms / Comparison Groups

Experimental: Panitumumab 6 mg/kg every 2 weeks

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

185

Estimated Completion Date

December 2008

Estimated Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00083616

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20030167

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP