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

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00004879

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Esophageal Cancer Kidney Cancer Lung Cancer Pancreatic Cancer Prostate Cancer	Biological: panitumumab	Phase 1

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2000

Actual Primary Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1738
2	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111