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Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004879
  Purpose

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 Intervention Phase
Colorectal Cancer
Esophageal Cancer
Kidney Cancer
Lung Cancer
Pancreatic Cancer
Prostate Cancer
Biological: panitumumab
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2000
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100% OR
  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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)

Renal:

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

Cardiovascular:

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

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • See Disease Characteristics
  • Recovered from any recent prior surgery

Other:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004879

Locations
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
Investigators
Principal Investigator: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067539, UCLA-9906078, ABX-EG-9901, UCLA-9906078-04B, NCI-G00-1673
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004879     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Urinary Tract Neoplasm
Prostatic Diseases
Genital Neoplasms, Male
Rectal Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Esophageal Neoplasms
Colonic Diseases
Urogenital Neoplasms
Urologic Neoplasms
Rectal Diseases
Antibodies, Monoclonal
Renal Cancer
Respiratory Tract Diseases
Urologic Diseases
Kidney Neoplasms
Lung Neoplasms
Kidney Diseases
Immunoglobulins
Endocrine Gland Neoplasms
Kidney Cancer
Digestive System Neoplasms
Rectal Neoplasm
Endocrine System Diseases
Esophageal Cancer
Genital Diseases, Male
Intestinal Diseases
Recurrence
Intestinal Neoplasms

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

ClinicalTrials.gov processed this record on July 02, 2009