Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery.

PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic (liver) metastases from colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Floxuridine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic colorectal adenocarcinoma

• Primary colorectal adenocarcinoma that has been completely resected (R0 disease)

• No evidence of residual, viable tumor by abdominal/pelvic helical CT scan or MRI with IV contrast

• Metastatic disease

• No more than 9 liver metastases

• All lesions completely resected or completely treated by ablation (with or without resection)

• All lesions treated by ablation must have been less than 5 cm in size and at least 5 mm away from main/left/right portal vein, common bile duct, and inferior vena cava

• All resected lesions must have a negative surgical margin (R0)

• Disease progression after prior systemic irinotecan for metastatic disease allowed

• No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection

• No other prior resection of extrahepatic metastases

• Must have the entire liver remnant perfused with a single catheter

• Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3

• Absolute granulocyte count at least 1,500/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 2 mg/dL

• Alkaline phosphatase no greater than 2.0 times upper limit of normal (ULN)

• AST and ALT no greater than 2.0 times ULN

• No active hepatitis B or C infection

• No histological evidence of cirrhosis

Renal

• Creatinine no greater than 1.5 times ULN

• Calcium less than 1.3 times ULN

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Postmenopausal women must be amenorrheic for at least 12 consecutive months to be deemed not fertile

• Medically fit to begin chemotherapy between 4 and 8 weeks after surgery

• Prior cancer allowed if all of the following criteria are met:

• Undergone potentially curative therapy for all prior malignancies

• No other malignancy within the past 5 years except the following:

• Effectively treated basal cell or squamous cell skin cancer

• Carcinoma in situ of the cervix that has been effectively treated by surgery alone

• Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone

• No evidence of recurrence of any prior malignancy

• No prior hepatic arterial infusion pump malfunction, malperfusion, or infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunologic or biologic therapy

Chemotherapy

• No prior chemotherapy within 4 weeks before hepatic resection or hepatic ablation (with or without resection)

• No prior hepatic arterial infusion with fluorouracil or floxuridine

Radiotherapy

• No concurrent adjuvant radiotherapy to the pelvis

• No other concurrent radiotherapy

Other

• No other concurrent systemic therapy