NCT00066274已完成2 期
Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 试验地点
- 17
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. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1.
- Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
- Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed colorectal carcinoma
- •Metastatic disease
- •Not amenable to surgery
- •Unidimensionally measurable disease
- •No bone metastases
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if hepatic metastases are present)
- •SGPT and SGOT no greater than 3 times ULN (5 times ULN if hepatic metastases are present)
- •Creatinine no greater than 1.25 times ULN
- •No concurrent cardiac abnormalities that would preclude study therapy
- •No concurrent pulmonary abnormalities that would preclude study therapy
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No chronic enteropathy
- •No other prior cancer within the past 5 years except carcinoma in situ of the cervix or curatively treated basal cell skin cancer
- •No concurrent severe uncontrolled infection
- •No obstruction or partial obstruction that would interfere with study therapy
- •No psychological, social, familial, or geographical situation that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent anticancer biological response modifiers
- •Chemotherapy
- •No prior chemotherapy (except adjuvant chemotherapy completed more than 6 months ago)
- •No prior irinotecan
- •No prior oxaliplatin
- •No other concurrent chemotherapy
- •Endocrine therapy
- •No concurrent anticancer hormonal therapy
- •Radiotherapy
- •At least 4 weeks since prior pelvic radiotherapy
- •No prior abdominopelvic radiotherapy
- •At least 4 weeks since prior surgery
- •No prior extensive intestinal resection (i.e., more than 1 prior hemicolectomy or extensive resection of the small intestines)
- •No other concurrent experimental medication
- •No other concurrent anticancer therapy
排除标准
- 未提供
研究者
研究点 (17)
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