Evaluating ABX-EGF (Panitumumab) Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00083616

Purpose

The purpose of this study is to determine that ABX-EGF (panitumumab) 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 (panitumumab)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Oxaliplatin Irinotecan U 101440E Irinotecan hydrochloride Panitumumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Duration of Response [ Time Frame: Until disease progression (median 7 weeks) ] [ Designated as safety issue: No ]
Duration of confirmed objective tumor response (complete or partial), centrally assessed per modified WHO criteria
Objective Tumor Response Through Week 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Confirmed objective tumor response (complete or partial response, i.e., at least a 50% decrease in target lesion size), based on modified WHO criteria, through week 16. Tumor response was assessed as "complete response," "partial response," "stable disease," or "disease progression." Confirmation 4 weeks after initial assessment was required.

Secondary Outcome Measures:

Objective Tumor Response Throughout Study [ Time Frame: Until disease progression (median 7 weeks) ] [ Designated as safety issue: No ]
Confirmed objective tumor response (complete or partial response, i.e., at least a 50% decrease in target lesion size), based on modified WHO criteria, throughout the study. Tumor response was assessed as "complete response," "partial response," "stable disease," or "disease progression." Confirmation 4 weeks after initial assessment was required
Time to Response [ Time Frame: Until disease progression (median 7 weeks) ] [ Designated as safety issue: No ]
Median time from enrollment to objective tumor response for participants who responded.
Progression-free Survival Time [ Time Frame: Until disease progression (median 7 weeks) ] [ Designated as safety issue: No ]
Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression
Time to Disease Progression [ Time Frame: Until disease progression (median 7 weeks) ] [ Designated as safety issue: No ]
Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death due to disease progression
Time to Treatment Failure [ Time Frame: Until disease progression (median 7 weeks) ] [ Designated as safety issue: No ]
Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment
Duration of Stable Disease [ Time Frame: Until disease progression (median 7 weeks) ] [ Designated as safety issue: No ]
Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease
Overall Survival [ Time Frame: Until disease progression (median 7 weeks) ] [ Designated as safety issue: No ]
Kaplan-Meier estimate of median time from enrollment to death from any cause

Enrollment:	185
Study Start Date:	March 2004
Study Completion Date:	December 2008
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Open label, single arm ABX-EGF (panitumumab) 6 mg/kg every 2 weeks	Drug: ABX-EGF (panitumumab) 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083616

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00083616 History of Changes
Obsolete Identifiers:	NCT00087243
Other Study ID Numbers:	20030167
Study First Received:	May 26, 2004
Results First Received:	August 6, 2010
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

EGFr
Clinical Trial
Panitumumab
ABX-EGF
Immunex

Metastatic Cancer
Vectibix
Abgenix
Amgen

Additional relevant MeSH terms:

Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

Oxaliplatin
Irinotecan
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012