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Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the effect of hepatic resection of colorectal carcinoma followed by systemic chemotherapy on 2 year disease free survival .

Outcome Time Frame:

2 years after treatment

Safety Issue:

No

Principal Investigator

Lucille A. Leong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

94080

NCT ID:

NCT00002842

Start Date:

September 1994

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010