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Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00039273
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 8, 2013
National Cancer Institute (NCI)
Information provided by:
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: panitumumab Phase 2

Detailed Description:


  • Determine the response rate of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF.
  • Determine the additional measures of clinical efficacy of this drug, in terms of progression-free survival, overall survival, and time to treatment failure, in these patients.
  • Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody ABX-EGF IV over 1 hour weekly on weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Primary Purpose: Treatment
Official Title: An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma
Study Start Date : July 2002
Actual Primary Completion Date : May 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed colorectal carcinoma

    • Diagnosed by fine-needle aspirate or tissue biopsy
    • Metastatic disease
    • No squamous cell carcinoma
  • Relapsed or refractory after prior chemotherapy with irinotecan and a fluoropyrimidine (i.e., fluorouracil, capecitabine, or ftorafur with or without leucovorin calcium) given concurrently or sequentially

    • Progressive disease within 2 months of last dose of this prior chemotherapy for metastatic disease OR
    • Evidence of relapse within 12 months after last dose of adjuvant therapy
  • Bidimensionally measurable disease
  • Overexpression of epidermal growth factor r (EGFr) by immunohistochemistry

    • Must be 2+ or 3+ in at least 10% of evaluated tumor cells
  • No known brain metastases



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN


  • Creatinine no greater than 2.2 mg/dL


  • LVEF at least 45% by MUGA
  • No myocardial infarction within the past year


  • HIV negative
  • No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
  • No chronic medical or psychiatric condition that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study


Biologic therapy:

  • No prior EGFr-targeting agents or biological agents with antitumor activity


  • See Disease Characteristics
  • At least 30 days since prior systemic chemotherapy
  • No more than 2 prior fluoropyrimidine regimens (e.g., fluorouracil and leucovorin calcium followed by capecitabine)
  • No other prior chemotherapy, except leucovorin calcium, for colorectal carcinoma

Endocrine therapy:

  • Not specified


  • At least 30 days since prior radiotherapy


  • Not specified


  • At least 30 days since other prior anticancer therapy
  • No prior investigational drug with potential antitumor activity
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00039273

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Joel Randolph Hecht, MD Jonsson Comprehensive Cancer Center
Publications of Results:
Meropol NJ, Berlin J, Hecht JR, et al.: Multicenter study of ABX-EGF monotherapy in patients with metastatic colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1026, 256, 2003.

Layout table for additonal information Identifier: NCT00039273    
Other Study ID Numbers: CDR0000069368
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by Jonsson Comprehensive Cancer Center:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents