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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00002842
First received: November 1, 1999
Last updated: February 28, 2017
Last verified: February 2017
November 1, 1999
February 28, 2017
September 1994
May 2014   (Final data collection date for primary outcome measure)
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.
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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: None (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
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
Interventions:
  • Drug: floxuridine
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
May 2014
May 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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002842
94080
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-IRB-94080
NCI-V96-1031
CDR0000065077 ( Registry Identifier: NCI PDQ )
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City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Study Chair: Lucille A. Leong, MD City of Hope Comprehensive Cancer Center
City of Hope Medical Center
February 2017

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