NCT00087334终止1 期
A Phase I/II Study of Capecitabine (XELODA®, Roche) Plus Oxaliplatin (Eloxatin®, Sanofi) Plus ZD 1893 (IRESSA®) in the Treatment of Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining capecitabine and oxaliplatin with gefitinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and gefitinib and to see how well they work in treating patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of capecitabine when given in combination with oxaliplatin and gefitinib in patients with metastatic colorectal cancer. (phase I)
- Determine the response rate in patients treated with this regimen. (phase II)
Secondary
- Determine the safety and toxic effects of this regimen in these patients.
- Determine the 1-year survival of patients treated with this regimen. (phase II)
- Determine the progression-free and overall survival of patients treated with this regimen. (phase II)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed* colorectal cancer
- •Metastatic disease
- •The site of the primary tumor must have been confirmed endoscopically, radiologically, or surgically to be the colon or rectum NOTE: *Confirmation is not required for recurrent metastatic disease unless an interval of > 5 years has elapsed between the initial primary surgery and the development of metastases
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL (transfusion allowed)
- •AST and ALT ≤ 3 times upper limit of normal (ULN)
- •Bilirubin ≤ ULN
- •No unstable or uncompensated hepatic disease
- •Creatinine < 1.5 times ULN OR
- •Creatinine clearance > 60 mL/min
- •No unstable or uncompensated renal disease
- •Cardiovascular
- •No unstable or uncompensated cardiac disease
- •No evidence of clinically active interstitial lung disease
- •Asymptomatic patients with chronic stable radiographic changes are eligible
- •No unstable or uncompensated respiratory disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No known hypersensitivity to gefitinib or any of its excipients
- •No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine
- •No severe or uncontrolled systemic disease
- •Able to receive oral medication
- •No known dihydropyrimidine dehydrogenase (DPD) deficiency
- •No known peripheral neuropathy ≥ grade 1
- •Absence of deep tendon reflexes as the sole neurological abnormality allowed
- •No other significant clinical disorder or laboratory finding that would preclude study participation
- •No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix (phase II only)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I)
- •No prior chemotherapy for metastatic disease (phase II)
- •Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed provided the last treatment was administered more than 6 months before the development of metastatic disease
- •No prior irinotecan and oxaliplatin (phase II)
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No concurrent radiotherapy for colorectal cancer
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
Response rate
次要结局
- Toxicity
- 1-year survival (phase II)
- Progression-free survival (phase II)
- Overall survival in (phase II)
研究者
研究点 (2)
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