A Randomized Phase I/III Study Of Systematic Chemotherapy With Or Without Hepatic Chemoembolization For Liver-Dominant Metastatic Adenocarcinoma Of The Colon And Rectum
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 试验地点
- 9
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known if chemoembolization is more effective than standard chemotherapy in treating metastatic cancer.
PURPOSE: This phase I trial and randomized phase III trial is studying the effectiveness of chemoembolization in treating patients who have colorectal cancer metastatic to the liver.
详细描述
OBJECTIVES:
- Compare the survival of patients with liver-dominant metastatic colorectal adenocarcinoma treated with irinotecan, fluorouracil, and leucovorin calcium with or without hepatic chemoembolization.
- Compare response in the liver, time to hepatic tumor progression, and time to extrahepatic tumor progression in patients treated with these regimens.
- Compare the possible treatment differences with respect to morbidity, toxic effects of chemoembolization, toxic effects of chemotherapy, and death from cancer-related complications in these patients.
OUTLINE: This is a phase I dose-escalation study followed by a phase III randomized, multicenter study. (Phase I closed as of 10/14/02.)
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Phase I: Patients in phase I are sequentially enrolled to 1 of 3 treatment regimens. (Phase I closed as of 10/14/02.)
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Regimen A: Patients receive irinotecan IV over 60-90 minutes, leucovorin calcium IV, and fluorouracil IV over 10 minutes on days 1, 8, 15, and 22. Patients undergo hepatic embolization with embolic suspension only on day 36.
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Regimen B: Patients receive chemotherapy as in regimen A. Patients undergo hepatic chemoembolization with lower-dose cisplatin, doxorubicin, and mitomycin on day 36.
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Regimen C: Patients receive chemotherapy as in regimen A. Patients undergo hepatic chemoembolization with higher-dose cisplatin, doxorubicin, and mitomycin on day 36.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic colorectal adenocarcinoma
- •Measurable metastasis to liver at least 1.0 cm
- •Less than 75% of total liver volume
- •Known extrahepatic disease limited to lymph nodes and less than 2 cm
- •No ascites
- •Ineligible for surgery
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count at least 2,000/mm^3
- •Platelet count at least 90,000/mm^3
- •No bleeding diathesis not correctable by standard therapy
- •Ineligible if all of the following criteria are concurrently present:
- •High risk of hepatic failure (more than 50% liver involvement by tumor)
- •Bilirubin greater than 2.0 mg/dL
- •SGOT greater than 100 U/L
- •Lactate dehydrogenase greater than 425 U/L
- •No hepatic encephalopathy
- •No portal vein occlusion without hepatopedal collateral flow demonstrated by angiography
- •No portal hypertension with hepatofugal flow
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No evidence of congestive heart failure
- •No severe peripheral vascular disease that would preclude catheterization
- •No severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No more than 1 prior adjuvant immunotherapy regimen for colon cancer
- •Chemotherapy:
- •At least 6 months since prior adjuvant chemotherapy and recovered
- •No more than 1 prior adjuvant chemotherapy regimen for colon cancer
- •No prior hepatic arterial infusion chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 1 month since prior radiotherapy
- •No prior hepatic radiotherapy
- •At least 1 month since prior surgery
- •Prior surgical resection or ablation of liver metastases allowed
- •No other concurrent therapy
排除标准
- 未提供