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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00002842
First received: November 1, 1999
Last updated: June 17, 2013
Last verified: June 2013

November 1, 1999
June 17, 2013
September 1994
September 2014   (final data collection date for primary outcome measure)
To evaluate the effect of hepatic resection of colorectal carcinoma followed by systemic chemotherapy on 2 year disease free survival . [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00002842 on ClinicalTrials.gov Archive Site
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Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Metastatic Cancer
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
Not Provided
September 2014   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Physiologic 18 to 70

Performance status:

  • Karnofsky 60%-100%

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • No second malignancy within 5 years except adequately treated:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior mitomycin or nitrosoureas allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • Not specified
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002842
94080, P30CA033572, CHNMC-IRB-94080, NCI-V96-1031, CDR0000065077
Not Provided
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Study Chair: Lucille A. Leong, MD Beckman Research Institute
City of Hope Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP