NCT00027729已完成1 期
Phase I/II Study of MEDI-522, A Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Irinotecan-Refractory Advanced Colorectal Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer that has not responded to irinotecan.
详细描述
OBJECTIVES:
- Determine the recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with irinotecan-refractory advanced colorectal cancer.
- Determine the safety and tolerance of this drug in these patients.
- Determine any antitumor activity of this drug in these patients.
- Determine the objective response rate, response duration, and time to progression in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes once weekly on weeks 1-52 in the absence of disease progression or unacceptable toxicity. Patients with responding disease may continue therapy.
Cohort of 4-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose in the phase II portion of the study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 advanced colorectal cancer
- •Disease progression while receiving an irinotecan-containing regimen for metastatic colorectal cancer OR
- •Disease recurrence within 6 months after completing an irinotecan-containing regimen in the adjuvant setting
- •At least 1 measurable lesion (for phase II only)
- •At least 20 mm by x-ray, CT scan, MRI, or photograph
- •Recurrent disease after surgery or radiotherapy is considered measurable if it has been at least 4 weeks since treatment and measurable disease is outside the port of prior radiotherapy or there is evidence of disease progression within the port of prior radiotherapy
- •The following are not considered measurable:
- •Pleural effusion
- •Osteoblastic lesion or evidence of disease on bone scan alone
- •Progressive irradiated lesions alone
- •Bone marrow involvement
- •Brain metastases
- •Malignant hepatomegaly by physical exam alone
- •Chemical markers (e.g., carcinoembryonic antigen)
- •No known brain metastases or primary brain tumors
- •No symptomatic pleural effusion or ascites requiring paracentesis
- •No clinical evidence of bowel obstruction
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin greater than 10.0 g/dL
- •Bilirubin no greater than 2.0 mg/dL
- •AST/ALT no greater than 5 times upper limit of normal (ULN)
- •PT/PTT less than ULN OR
- •INR less than 1.12
- •No hepatitis virus infection
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 50 mL/min
- •Cardiovascular:
- •No prior myocardial infarction
- •No angina
- •No uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg)
- •No prior cerebrovascular accident or transient ischemic attack
- •No respiratory insufficiency requiring oxygen treatment
- •No lymphangitic involvement of lungs
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for 30 days before, during, and for 30 days after study
- •Thyroxine and thyroid-stimulating hormone normal
- •No hematemesis, melena, hematochezia, or gross hematuria
- •No prior significant adverse reaction to a humanized monoclonal antibody
- •No known HIV infection
- •No active infection requiring systemic anti-infective therapy
- •No other medical or psychological condition or behavior, including substance dependence or abuse, that would preclude study
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排除标准
- 未提供
研究者
研究点 (1)
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