Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	UCLA-9906078 ABX-EG-9901, UCLA-9906078-04B, NCI-G00-1673, NCT00004879

Objectives

1. Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer.
2. Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population.
3. Evaluate the clinical effect of this drug in this patient population.

Entry 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

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

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/mm³
• Platelet count greater than 100,000/mm³

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
• FEV₁ 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

Expected Enrollment

A total of 76 patients will be accrued for this study within approximately 14 months.

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Arie Belldegrun, MD, FACS, Principal investigator		Ph: 310-794-6584; 888-798-0719 Email: abelldegrun@mednet.ucla.edu

Registry Information
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
Trial Start Date		2000-04-17
Registered in ClinicalTrials.gov		NCT00004879
Date Submitted to PDQ		2000-01-07
Information Last Verified		2004-08-19
NCI Grant/Contract Number		CA16042

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