monoclonal antibody abx-egf in treating patients with renal (kidney), prostate, pancreatic, non-small cell lung, colon or rectal, esophageal, or gastroesophageal junction cancer

Conditions: Colorectal Cancer; Esophageal Cancer; Kidney Cancer; Lung Cancer; Pancreatic Cancer; Prostate 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.

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

Keywords: 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