Colon Cancer Clinical Trial

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

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.

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Full Description

OBJECTIVES:

Determine the toxicity of hepatic arterial infusion with floxuridine and systemic irinotecan adjuvant to liver metastases resection or ablation with or without resection in patients with hepatic metastases secondary to colorectal cancer.
Determine the overall survival of patients treated with this regimen.
Determine the time to any hepatic recurrence or progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (liver metastases resection only vs ablation with or without resection).

Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity.

Patients are followed every 3 months for 2 years.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

94

Study ID:

NCT00063960

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 10 Locations for this study

See Locations Near You

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Central Baptist Hospital
Lexington Kentucky, 40503, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Integris Oncology Services
Oklahoma City Oklahoma, 73112, United States
University Medical Group
Providence Rhode Island, 02908, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

94

Study ID:

NCT00063960

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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