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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004879
• Other study ID #: CDR0000067539
• Secondary ID: UCLA-9906078ABX-
• Status: Completed
• Phase: Phase 1
• First received: March 7, 2000
• Last updated: January 7, 2013
• Start date: April 2000

Study information

• Verified date: January 2013
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Kidney Cancer
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• panitumumab

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,