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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Esophageal Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer, Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Arie Belldegrun, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067539

NCT ID:

NCT00004879

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Esophageal Cancer
  • Kidney Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • recurrent renal cell cancer
  • recurrent prostate cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • recurrent non-small cell lung cancer
  • recurrent pancreatic cancer
  • recurrent esophageal cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111