Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver (6655)

Launched by AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK · Jun 16, 2003

Keywords

ClinConnect Summary

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-...

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Eligibility criteria

• 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:
• Age:
• • 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
• Hepatic:
• * 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
• Renal:
• • 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
• Other:
• • 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
• Surgery:
• • At least 1 month since prior surgery
• • Prior surgical resection or ablation of liver metastases allowed
• Other:
• • No other concurrent therapy