Evaluating ABX-EGF in Patients With Metastatic ColorectalCarcinoma

May 10, 2013 updated by: Amgen

An Open Label Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of ABX-EGF in Patients With Metastatic Colorectal Carcinoma

The purpose of this study is to determine if ABX-EGF is safe and efficacious in patients with metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Cohort A: - Pathologic diagnosis of colorectal carcinoma fine needle aspiration or tissue biopsy - Metastatic colorectal carcinoma - Must have previously failed therapy with a fluoropyrimidine and either irinotecan or oxaliplatin; may have received both irinotecan and oxaliplatin; chemotherapeutic agents may have been given concurrently or sequentially. - May have received prior radiotherapy (target lesions should not have been irradiated) - Bidimensionally measurable disease - Paraffin-embedded tumor tissue available for immunohistochemistry (IHC) studies of epidermal growth factor receptor (EGFr) expression (archived tissue is acceptable) - Tumor-expressing EGFr by immunohistochemistry (staining must be 2+ or 3+ in greater than or equal to 10% of evaluated tumor cells; staining and evaluation to be conducted at a central laboratory) - ECOG score of 0 or 1 - Adequate hematologic, renal, and hepatic function Cohort B: - The same inclusion criteria from Cohort A will apply to Cohort B, with the exception of the following tumor expressing EGFr criterion:

*Cohort B will include subjects who have IHC staining of 1+ present in greater than 10% evaluated tumor cells, OR IHC staining of the sum of 1+, 2+ and 3+ present in greater than 10% evaluated tumor cells but with the sum of 2+ and 3+ present in less than 10% evaluated tumor cells Exclusion Criteria: Cohorts A and B: - Female subject (e.g., of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized or not abstinent) who is not willing to use an oral or implanted contraceptive, double barrier birth control, or an intrauterine device (IUD) during the course of the study and for 6 months following the last ABX-EGF infusion - Female subject who is breast feeding or who has a positive serum pregnancy test within 72 hours prior to the first ABX-EGF infusion - Male subject who is not willing to use adequate contraception upon enrollment into this study and for 1 month following the last ABX-EGF infusion - Untreated brain metastases - Use of systemic chemotherapy or radiotherapy within 30 days prior to the first dose of ABX-EGF - Chemotherapy other than fluoropyrimidines, irinotecan or oxaliplatin for colorectal carcinoma. Leucovorin and levamisole are not considered as chemotherapy in this exclusion criterion. - Prior EGFr targeting agents - Prior investigational drugs with potential antitumor activity (experimental small molecules within 30 days prior to the first ABX-EGF infusion, experimental proteins/antibodies within 3 months prior to the first ABX-EGF infusion) - If prior history of cancer, other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, no treatment or active disease within 5 years - Myocardial infarction within past year - Left ventricular ejection fraction (LVEF) less than 45%, as measured by multiple-gated acquisition (MUGA) scan - Known to be HIV positive - History of any chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with the interpretation of study results - Subject allergic to the ingredients of the study medication or to Staphylococcus Protein A - Unwilling or unable to comply with the study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess Objective Response at Week 8 of Cycle 1

Secondary Outcome Measures

Outcome Measure
To evaluate additional measures of the clinical efficacy of ABX-EGF in subjects with metastatic colorectal carcinoma. (progression free survival, survival time, best overall response, and time to disease progression)
To determine the safety of ABX-EGF in subjects with metastatic colorectal carcinoma. (incidence of AEs, laboratory abnormalities, and other safety parameters)
To evaluate the safety and efficacy of ABX-EGF in subjects with lower tumor epidermal growth factor receptor (EGFr) expression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Registration Dates

First Submitted

May 25, 2005

First Submitted That Met QC Criteria

May 25, 2005

First Posted (Estimate)

May 26, 2005

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 10, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20025405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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