Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction 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: NCT00004879
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 such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Esophageal Cancer Kidney Cancer Lung Cancer Pancreatic Cancer Prostate Cancer Biological: panitumumab Phase 1

Detailed Description:


  • Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer.
  • Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population.
  • Evaluate the clinical effect of this drug in this patient population.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3* (enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on weeks 3-5.

NOTE: *All patients receive a total of 4 doses.

Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 or 3 patients experience dose-limiting toxicity.

Patients are followed every 2 weeks for 5 weeks.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within approximately 14 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small-Cell Lung, Colorectal, or Esophageal Cancer
Study Start Date : April 2000
Actual Primary Completion Date : July 2005

Information from the National Library of Medicine

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


  • Histologically confirmed diagnosis of 1 of the following:

    • Renal cell cancer (RCC)

      • Prior nephrectomy required
    • Prostate cancer

      • Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
      • Failed prior hormonal therapy (e.g., antiandrogen, luteinizing hormone-releasing hormone inhibitor, or orchiectomy)
    • Pancreatic cancer

      • Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
    • Non-small cell lung cancer

      • Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
    • Colorectal cancer

      • Received 1 or more prior chemotherapy regimen(s) for advanced metastatic disease
    • Esophageal cancer

      • Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
    • Gastroesophageal junction cancer
  • Evaluable disease
  • Epidermal growth factor receptor overexpression

    • Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of evaluated tumor cells
  • No uncontrolled brain metastases
  • No evidence of disease progression or regression after a 30-day washout period



  • 18 and over

Performance status:

  • Karnofsky 70-100% OR
  • ECOG 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
  • Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases)


  • Creatinine less than 2.2 mg/dL
  • NCI renal toxicity no greater than grade 2
  • No hypercalcemia (antihypercalcemic therapy allowed)


  • Ejection fraction at least 45% by MUGA
  • No abnormal ECG or MUGA
  • No myocardial infarction within the past year


  • No abnormal chest x-ray
  • FEV_1 greater than 50% of predicted


  • No known allergy to ingredients of study drug
  • No known allergy to Staphylococcus aureus Protein A
  • HIV negative
  • No chronic medical or psychiatric condition that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study participation


Biologic therapy:

  • At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or co-stimulatory pathway inhibitors)
  • No other concurrent biologic therapy


  • See Disease Characteristics
  • At least 6 weeks since prior chemotherapy and recovered
  • No prior chemotherapy for RCC
  • No prior anthracyclines
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • Concurrent steroids allowed
  • Concurrent hormonal therapy allowed


  • See Disease Characteristics
  • No prior mediastinal radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Recovered from any recent prior surgery


  • At least 30 days since prior investigational drug or device
  • At least 30 days since prior systemic therapy
  • No other concurrent investigational drugs
  • No other concurrent systemic agents or cancer therapy

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): NCT00004879

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1738
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center Identifier: NCT00004879     History of Changes
Other Study ID Numbers: CDR0000067539
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:
recurrent renal cell cancer
recurrent prostate cancer
recurrent colon cancer
recurrent rectal cancer
recurrent non-small cell lung cancer
recurrent pancreatic cancer
recurrent esophageal cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Esophageal Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Head and Neck Neoplasms
Esophageal Diseases
Urologic Neoplasms
Kidney Diseases
Urologic Diseases