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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00063960
First received: July 8, 2003
Last updated: February 6, 2009
Last verified: December 2005
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Drug: floxuridine
Drug: irinotecan hydrochloride
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Toxicity Assessment In Two Cohorts Of Patients (Resection Alone Or Ablation With Or Without Resection Of Hepatic Metastases From Colorectal Cancer) Treated With Adjuvant Hepatic Arterial Infusion (HAI) FUDR Plus Systemic CPT-11

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2003
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: A total of 28-94 patients (14-47 patients per stratum) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent adjuvant radiotherapy to the pelvis
  • No other concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No other concurrent systemic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063960

Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7213
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Oklahoma
Integris Oncology Services
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
University Medical Group
Providence, Rhode Island, United States, 02908-4735
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Yuman Fong, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00063960     History of Changes
Other Study ID Numbers: CDR0000305857, ACOSOG-Z05032
Study First Received: July 8, 2003
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
stage IV rectal cancer
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases
Floxuridine
Irinotecan
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014