Clinical Trial: 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.

Sponsors and Collaborators: American College of Surgeons
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage IV colon cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Stage IV rectal cancer
liver metastases
 Drug: floxuridine
 Drug: irinotecan
 Procedure: adjuvant therapy
 Procedure: chemotherapy
 Procedure: hepatic arterial infusion
Phase II

MedlinePlus related topics:  Colorectal Cancer;   Liver Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Adjuvant Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan in Patients With Hepatic Metastases Secondary to Colorectal Cancer

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

Endocrine therapy

  • Not specified

Radiotherapy

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

Surgery

  • See Disease Characteristics

Other


Location Information


Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States

Kentucky
      Central Baptist Hospital, Lexington,  Kentucky,  40503-9985,  United States

Massachusetts
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7213,  United States

Oklahoma
      Integris Oncology Services, Oklahoma City,  Oklahoma,  73112,  United States

Rhode Island
      University Medical Group, Providence,  Rhode Island,  02908-4735,  United States

Study chairs or principal investigators

Yuman Fong, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000305857; ACOSOG-Z05032; NCT00063960
Record last reviewed:  January 2005
Last Updated:  January 7, 2005
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00063960
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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