Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

Colorectal Cancer Clinical Trial

Official title:

A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002692
• Other study ID #: CDR0000064434
• Secondary ID: MRC-CR05EU-95032
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 18, 2013
• Start date: December 1994

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous infusion or intrahepatic infusion of fluorouracil and leucovorin in treating patients with colorectal cancer metastatic to the liver.

Description:

OBJECTIVES: I. Compare the survival and response rates of patients with colorectal liver metastases treated with intravenous vs. intrahepatic arterial infusion of fluorouracil/leucovorin. II. Assess the effect of these 2 treatments on symptoms and quality of life of these patients.

OUTLINE: Randomized study. Patients randomized to Arm II should have a preoperative hepatic angiography; at laparotomy, an intrahepatic arterial catheter is fused into the gastroduodenal artery to establish an infusion of both lobes of the liver. Arm I: Single-Agent Chemotherapy with Drug Modulation. Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, CF, NSC-3590. Intravenous infusion. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Intrahepatic arterial infusion.

PROJECTED ACCRUAL: 312 patients are expected to be randomized within 3-4 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 312
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum with metastases confined to the liver and not amenable to surgery

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3.5 mg/dL (50 micromoles/liter) Renal: Not specified Cardiovascular: No uncontrolled heart disease (e.g., congestive heart failure, angina) Other: No uncontrolled infection No other uncontrolled medical illness

PRIOR CONCURRENT THERAPY: No prior fluorouracil (5-FU) for advanced disease More than 6 months since adjuvant 5-FU (e.g., in AXIS or QUASAR studies)

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• fluorouracil

• isolated perfusion

• leucovorin calcium

Locations

Country	Name	City	State
United Kingdom	University Birmingham	Birmingham	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

McArdle C, Kerr DJ, Ledermann J, et al.: Intravenous (IV) vs intrahepatic (IHA) 5FU/leucovorin for colorectal (CRC) liver metastases: preliminary results of the MRC CR05/EORTC 40972 randomised trial. [Abstract] Proceedings of the American Society of Clini

McArdle C, Kerr DJ, Ledermann J, et al.: Intravenous (IV) vs intrahepatic arterial (IHA) 5-FU/leucovorin for colorectal (CRC) liver metastasis: preliminary results of the MRC CRO5/EORTC 40972 randomised trial. [Abstract] Eur J Cancer 37 (suppl 6): A-955,

McArdle C: IV versus IHA 5FU/leucovorin for colorectal liver metastases: preliminary results of the MRC CR05 EORTC 40972 randomised trial. [Abstract] Br J Cancer 85 (suppl 1): A-CT2. 1, 2001.