Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002692
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: May 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
 Drug: fluorouracil
Drug: isolated perfusion
Drug: leucovorin calcium
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 312
Study Start Date: December 1994
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002692

Locations
United Kingdom
University Birmingham
Birmingham, England, United Kingdom, B15 2TT
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: David J. Kerr, MD, FRCP, DSc University Hospital Birmingham
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.
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 Clinical Oncology 20: A-499, 2001.
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, s257, 2001.

ClinicalTrials.gov Identifier: NCT00002692     History of Changes
Other Study ID Numbers: CDR0000064434, MRC-CR05, EU-95032
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
 adenocarcinoma of the colon
adenocarcinoma of the rectum
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
 Fluorouracil
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on May 23, 2013