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

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ClinicalTrials.gov Identifier: NCT00002842
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Results First Submitted Date  ICMJE February 28, 2017
Results First Posted Date  ICMJE April 11, 2017
Last Update Posted Date April 11, 2017
Study Start Date  ICMJE September 1994
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00002842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
Official Title  ICMJE Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma
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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Metastatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2014)
49
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002842
Other Study ID Numbers  ICMJE 94080
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-IRB-94080
NCI-V96-1031
CDR0000065077 ( Registry Identifier: NCI PDQ )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Lucille A. Leong, MD City of Hope Comprehensive Cancer Center
PRS Account City of Hope Medical Center
Verification Date February 2017

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