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PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY


Phase 3
18 Years
76 Years
Open (Enrolling)
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY


OBJECTIVES: I. Compare the efficacy of 2 schedules of fluorouracil/leucovorin given as a
continuous intra-arterial infusion via an implantable pump vs. a subcutaneous port for
unresectable liver metastases in patients with colorectal cancer. II. Compare the effect of
each treatment on response rate, quality of life, and rate of technical complications in
these patients.

OUTLINE: Randomized study. The following acronyms are used: CF Leucovorin calcium, NSC-3590
5-FU Fluorouracil, NSC-19893 Arm I: Single-Agent Chemotherapy with Drug Modulation. 5-FU;
with CF. Weekly infusion via an implantable pump. Arm II: Single-Agent Chemotherapy with
Drug Modulation. 5-FU; with CF. Weekly infusion via a subcutaneous infusion port. Arm III:
Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via an
implantable pump. Arm IV: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF.
Monthly infusion via a subcutaneous infusion port.

PROJECTED ACCRUAL: A total of 336 patients will be entered in this multicenter study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Primary colorectal cancer with unresectable liver metastases Less
than 75% involvement of the liver Radical resection of primary colon or rectal tumor
required No local recurrence or extrahepatic metastases No portal vein thrombosis,
ascites, or cirrhosis

PATIENT CHARACTERISTICS: Age: 18 to 76 Performance status: Karnofsky 70%-100%
Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Bilirubin no
greater than 4 mg/dL Alkaline phosphatase no greater than 1,200 U/L Coagulation tests
normal Renal: Creatinine no greater than 2.5 mg/dL Other: No prior malignancy

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior intra-arterial chemotherapy
for liver metastases No prior hepatic chemoembolization At least 3 months since
fluorouracil

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Matthias Lorenz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Klinikum der J.W. Goethe Universitaet

Authority:

United States: Federal Government

Study ID:

CDR0000064871

NCT ID:

NCT00002793

Start Date:

January 1991

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
  • Liver Neoplasms

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