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

NCT ID: NCT00063960

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2004-12-31

Brief 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.

Detailed 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.

Conditions

Colorectal Cancer; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

floxuridine + irinotecan

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.

Group Type: EXPERIMENTAL

floxuridine

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Interventions

floxuridine

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuman Fong, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Integris Oncology Services

Oklahoma City, Oklahoma, United States

University Medical Group

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

ACOSOG-Z05032

Identifier Type: -

Identifier Source: secondary_id

CDR0000305857

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACOSOG-Z05032

Identifier Type: -

Identifier Source: org_study_id