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| Sponsor: | Medical Research Council |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002692 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES |
| Estimated Enrollment: | 312 |
| Study Start Date: | December 1994 |
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 |
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| United Kingdom, England | |
| University Birmingham | |
| Birmingham, England, United Kingdom, B15 2TT | |
| Study Chair: | David J. Kerr, MD, FRCP, DSc | University Hospital Birmingham |
More Information
| Study ID Numbers: | CDR0000064434, MRC-CR05, EU-95032 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002692 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
adenocarcinoma of the colon adenocarcinoma of the rectum liver metastases |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Neoplastic Processes Neoplasms by Site Pathologic Processes Vitamins Therapeutic Uses |
Neoplasm Metastasis Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
