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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

December 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002692 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized

Condition ^ICMJE

Colorectal Cancer
Metastatic Cancer

Intervention ^ICMJE

Drug: fluorouracil
Drug: isolated perfusion
Drug: leucovorin calcium

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

312

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00002692

Responsible Party

Study ID Numbers ^ICMJE

CDR0000064434, MRC-CR05, EU-95032

Study Sponsor ^ICMJE

Medical Research Council

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

David J. Kerr, MD, FRCP, DSc

University Hospital Birmingham

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP