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Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002842
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus systemic fluorouracil and leucovorin in treating patients with liver metastases from colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Drug: floxuridine Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: conventional surgery Phase 2

Detailed Description:


  • Evaluate the efficacy of hepatic resection followed by portal vein infusion of floxuridine plus systemic fluorouracil/leucovorin calcium in patients with metastatic colorectal cancer.
  • Study the toxic effects of adjuvant chemotherapy following hepatic resection.
  • Evaluate mRNA expression of enzymes that may be important to the cytotoxicity of fluoropyrimidines in tumor cells, including thymidylate synthase, ribonucleotide reductase, and folylglutamyl synthetase, by polymerase chain reaction and immunohistochemistry.

OUTLINE: Following resection of the liver and all extrahepatic colorectal cancer, patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks.

If biopsy-proven metastatic disease develops, treatment may be stopped at the investigator's discretion. Continuation of regional therapy should be considered for extrahepatic failure. No concurrent radiotherapy is permitted.

Patients are followed every 3 months for 3 years, then every 6 months for survival.

PROJECTED ACCRUAL: It is expected that 50 patients will be entered over approximately 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma
Study Start Date : September 1994
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin
Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks
Drug: floxuridine
Starting dose of 0.2 mg/kg/day for 14 consecutive days.

Drug: fluorouracil
300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.

Drug: leucovorin calcium
500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.

Procedure: adjuvant therapy
Chemotherapy given after hepatic resection

Procedure: conventional surgery
Hepatic resection

Primary Outcome Measures :
  1. 2 Year Disease-free Survival . [ Time Frame: 2 years after treatment ]
    Estimated using the product-limit method of Kaplan and Meier. Disease free survival, defined as first documented evidence of treatment failure. Acceptable evidence includes: Anastomotic - positive cytology or biopsy; Abdominal, pelvic and retroperitoneal nodes - progressively enlarging node as evidenced by 2 CT scans separated by at least a 4 week interval, ureteral obstruction in the presence of a mass as documented on CT scan; Peritoneum - positive cytology or biopsy, progressively enlarged intraperitoneal solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Ascites - positive cytology or biopsy; Liver - positive cytology or biopsy; Pelvic mass - positive cytology or biopsy, progressively enlarging intrapelvic solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Abdominal wall - positive cytology or biopsy; Lung - positive cytology or biopsy or presence of multiple pulmonary nodules; Bone marrow - positive cytology, aspiration or biopsy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed colorectal carcinoma or radiologically confirmed colorectal carcinoma in a synchronous metastasis
  • Intrahepatic metastases required

    • No more than 15 metastases involving no more than 60% of functioning liver
  • No extrahepatic disease unless:

    • Resectable anastomotic or locally recurrent tumor
    • Resectable mesenteric lymph node involvement in patients undergoing initial resection of primary colorectal carcinoma
    • Disease extension from liver metastasis amenable to en bloc resection (e.g., diaphragm wall, kidney, abdominal wall)
  • No biopsy-proven chronic active hepatitis



  • Physiologic 18 to 70

Performance status:

  • Karnofsky 60%-100%


  • AGC at least 1,500
  • Platelets at least 100,000


  • Bilirubin no greater than 2.0 mg/dL (unless reversibly obstructed by metastasis)


  • Creatinine no greater than 2.0 mg/dL


  • No second malignancy within 5 years except adequately treated:

    • Nonmelanomatous skin cancer
    • In situ bladder cancer
    • In situ cervical cancer
    • No pregnant women


Biologic therapy:

  • Not specified


  • Prior mitomycin or nitrosoureas allowed

Endocrine therapy:

  • Not specified


  • No prior radiotherapy to the liver
  • At least 3 weeks since radiotherapy and recovered
  • Prior pelvic radiotherapy allowed
  • No planned concurrent radiotherapy


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002842

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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
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Study Chair: Lucille A. Leong, MD City of Hope Comprehensive Cancer Center

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Responsible Party: City of Hope Medical Center Identifier: NCT00002842    
Other Study ID Numbers: 94080
P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000065077 ( Registry Identifier: NCI PDQ )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: February 2017
Keywords provided by City of Hope Medical Center:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
liver metastases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Protective Agents