NCT00049101已完成1 期
A Phase I/II Study Of OSI-774 In Combination With Oxaliplatin, And 5-Fluourouracil In Patients With Metastatic Colorectal Carcinoma
适应症
相关药物
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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining erlotinib with combination chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib with oxaliplatin, leucovorin, and fluorouracil in treating patients who have metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of erlotinib when administered with oxaliplatin, leucovorin calcium, and fluorouracil in patients with metastatic colorectal cancer.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine any antitumor activity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the objective response rate and response duration in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a dose-escalation study of erlotinib.
- Phase I: During the first week of the first course only, patients receive oral erlotinib daily alone. Patients then begin the regular schedule comprising oral erlotinib daily, oxaliplatin IV over 2 hours on day 1, and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 2 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 colon or rectal cancer
- •Metastatic or unresectable disease
- •Unidimensionally measurable disease required for phase II only
- •At least 20 mm by x-ray, CT scan, MRI, or photography
- •The following are not considered measurable:
- •Pleural effusion or ascites
- •Osteoblastic lesions
- •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)
- •Recurrent disease after surgery or radiotherapy is considered measurable as long as the following criteria are met:
- •At least 4 weeks since prior surgery or radiotherapy
- •Measurable disease exists outside the radiation port or clear progression exists within the radiation port
- •Tissue accessible for immunohistochemical evidence of epidermal growth factor receptor expression from a metastatic site (phase II only)
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST/ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •No unstable angina pectoris
- •No symptomatic congestive heart failure
- •No cardiac arrhythmia
- •No uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg)
- •No abnormalities of the cornea (e.g., severe dry eye syndrome or Sjogren's syndrome)
- •No congenital abnormality (e.g., Fuch's dystrophy)
- •No abnormal slit-lamp examination using vital dye (e.g., fluorescein or Bengal-Rose)
- •No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear-production test)
- •Mild dry eye syndrome allowed if patient can use artificial tears and ophthalmologist concurs
- •Gastrointestinal
- •No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
- •No active peptic ulcer disease
- •Must be able and willing to undergo a mediport insertion
- •Not pregnant or nursing
- •Negative pregnancy test
- 另有 29 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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