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Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV

Phase 2
75 Years
Open (Enrolling)
Colorectal Cancer, Metastatic Cancer

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Trial Information

Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV

OBJECTIVES: I. Determine the efficacy and tolerance of oxaliplatin by hepatic perfusion
combined with intravenous leucovorin calcium and fluorouracil in patients with liver
metastases from colorectal cancer.

OUTLINE: Patients receive oxaliplatin by hepatic perfusion over 2 hours on day 1 plus
leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2.
Treatment repeats every 14 days in the absence of disease progression or unacceptable
toxicity. If a good response is achieved after 8 courses of chemotherapy, patients may
undergo surgical resection of metastases.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven colorectal cancer metastatic to the liver
Unresectable disease Less than 50% invasion of the liver Measurable disease No prior
irradiation Largest diameter at least 20 mm No detectable extrahepatic disease

PATIENT CHARACTERISTICS: Age: Under 75 Performance status: WHO 0-2 Life expectancy:
Greater than 2 months Hematopoietic: WBC at least 4,000/mm3 Neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 35 micromoles/L
Renal: Creatinine less than 130 micromoles/L Cardiovascular: No severe cardiac
insufficiency Pulmonary: No respiratory disease that would preclude study Other: No other
serious illness that would preclude study No psychological illness that would preclude
study No peripheral neuropathy No prior malignancy not considered cured Not pregnant
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
intravenous oxaliplatin No more than 1 prior regimen of intravenous chemotherapy for
metastatic disease Primary chemotherapy of fluorouracil allowed if stable or progressive
disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy
Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michel Ducreux, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


United States: Federal Government

Study ID:




Start Date:

January 1999

Completion Date:

Related Keywords:

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