Clinical Trial: 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 no longer recruiting patients.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
Colorectal Cancer
Esophageal Cancer
kidney tumor
Lung Cancer
Pancreatic Cancer
Prostate Cancer
 Drug: monoclonal antibody ABX-EGF
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: monoclonal antibody therapy
Phase I

MedlinePlus related topics:  Colorectal Cancer;   Esophageal Cancer;   Kidney Cancer;   Lung Cancer;   Pancreatic Cancer;   Prostate Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Monoclonal Antibody ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small Cell Lung, Colorectal, Esophageal, or Gastroesophageal Junction Cancer

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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:


Location Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1738,  United States

Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

Study chairs or principal investigators

Arie Belldegrun, MD, FACS,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067539; UCLA-9906078; ABX-EG-9901; UCLA-9906078-04B; NCI-G00-1673
Record last reviewed:  November 2004
Last Updated:  November 4, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004879
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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