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

• Status: Terminated
• Trial end date: 2002-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American College of Radiology Imaging Network
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Mitomycin; Mitomycins

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