Monoclonal Antibody ABX-EGF In Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon Or Rectal, Esophageal, Or Gastroesophageal Junction Cancer

Study Overview

Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer

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.

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.

Colorectal Cancer
Esophageal Cancer
Kidney Cancer
Lung Cancer
Pancreatic Cancer
Prostate Cancer

BIOLOGICAL: panitumumab

CDR0000067539
UCLA-9906078
ABX-EG-9901
UCLA-9906078-04B
NCI-G00-1673

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2000-03-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-01-07
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-01-08
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2013-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Karnofsky 70-100% OR
ECOG 0-1

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Arie Belldegrun, MD, FACS, Jonsson Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record