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

NCT ID: NCT00004879

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30

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.

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

panitumumab

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Arie Belldegrun, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UCLA-9906078

Identifier Type: -

Identifier Source: secondary_id

ABX-EG-9901

Identifier Type: -

Identifier Source: secondary_id

UCLA-9906078-04B

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1673

Identifier Type: -

Identifier Source: secondary_id

CDR0000067539

Identifier Type: -

Identifier Source: org_study_id