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
panitumumab
Urogenital Diseases+44
+ Genital Diseases
+ Adenocarcinoma
Treatment Study
Summary
Study start date: April 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesOpen Jonsson Comprehensive Cancer Center, UCLA in Google MapsFox Chase Cancer Center
Philadelphia, United States