NCT00025350已完成2 期
A Randomized Phase II Trial of Two Dose Levels of ZD1839 (Iressa) (NSC 715055, IND 61187) in Patients With Recurrent Colorectal Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 16
研究概览
简要总结
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of recurrent metastatic colorectal cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of gefitinib in treating patients who have recurrent metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Determine the 4-month progression-free survival rate in patients with recurrent metastatic colorectal adenocarcinoma treated with gefitinib.
- Determine the objective tumor response rate, progression, and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to ECOG performance status (0-1 vs 2), baseline serum CEA (less than 5 mg/L vs at least 5 mg/L), and number of metastatic sites (1 vs 2 or more). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral gefitinib once daily (twice daily on day 1 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive a higher dose of oral gefitinib as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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 or cytologically proven adenocarcinoma of the colon or rectum
- •Measurable disease
- •Evidence of new or progressive metastatic disease within 6 months of last treatment
- •Must have received prior systemic treatment with fluorouracil (and/or its analogs, with or without leucovorin calcium or levamisole) and irinotecan in the adjuvant or metastatic setting
- •Metastatic tumor site accessible for biopsy
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST or ALT no greater than 2.5 times ULN (5 times ULN if tumor involvement of the liver)
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No ongoing active or uncontrolled infections
- •Other prior malignancies allowed provided prior therapy is discontinued and no evidence of disease
- •No other uncontrolled illness or psychiatric illness/social situations that would preclude study
- •Must be able to take and retain oral medications
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior signal transduction inhibitors (e.g., vascular endothelial growth factor-, vascular endothelial growth factor receptor-, and epidermal growth factor receptor-targeted agents) for colorectal cancer
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and recovered
- •No other prior cytotoxic chemotherapy (e.g., oxaliplatin) for colorectal cancer
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •Not specified
- •No other prior systemic therapy for colorectal cancer
- •No other prior investigational or approved agents for colorectal cancer
- •No other concurrent investigational agents
- •No concurrent antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究者
研究点 (16)
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