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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Carcinoma

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess Objective Response at Week 8 of Cycle 1

Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Carcinoma
  • Colon Cancer, Rectal Cancer
  • Colorectal Carcinoma, EGFr
  • Metastatic Cancer, ABX-EGF
  • Panitumumab, Abgenix
  • Clinical Trial, Immunex, Amgen
  • Metastatic Colorectal
  • Carcinoma
  • Colorectal Neoplasms