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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status:
- •Karnofsky 70-100% OR
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •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)
- •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
- •No abnormal chest x-ray
- •FEV_1 greater than 50% of predicted
- •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:
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排除标准
- 未提供