Colorectal Cancer, Esophageal Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer, Prostate Cancer
Conditions
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
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.
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.
Interventions
BIOLOGICALpanitumumab
Sponsors
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed