Prostate Cancer Clinical Trial
Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
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.
Full 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.
Eligibility 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
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There are 2 Locations for this study
Los Angeles California, 90095, United States
Philadelphia Pennsylvania, 19111, United States
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