Chemotherapy Via an Implantable Pump Compared With a Subcutaneous Port for Unresectable Liver Metastases in Patients With Resected Colorectal Cancer

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:
NCT00002793
First received: November 1, 1999
Last updated: September 16, 2013
Last verified: May 2007
  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 or giving the drugs in different ways may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy administered via an implantable pump with a subcutaneous port for unresectable liver metastases in patients with resected primary colorectal cancer.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY

Resource links provided by NLM:


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

Estimated Enrollment: 336
Study Start Date: January 1991
Detailed Description:

OBJECTIVES: I. Compare the efficacy of 2 schedules of fluorouracil/leucovorin given as a continuous intra-arterial infusion via an implantable pump vs. a subcutaneous port for unresectable liver metastases in patients with colorectal cancer. II. Compare the effect of each treatment on response rate, quality of life, and rate of technical complications in these patients.

OUTLINE: Randomized study. The following acronyms are used: CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 Arm I: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via an implantable pump. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via a subcutaneous infusion port. Arm III: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via an implantable pump. Arm IV: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via a subcutaneous infusion port.

PROJECTED ACCRUAL: A total of 336 patients will be entered in this multicenter study.

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Primary colorectal cancer with unresectable liver metastases Less than 75% involvement of the liver Radical resection of primary colon or rectal tumor required No local recurrence or extrahepatic metastases No portal vein thrombosis, ascites, or cirrhosis

PATIENT CHARACTERISTICS: Age: 18 to 76 Performance status: Karnofsky 70%-100% Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Bilirubin no greater than 4 mg/dL Alkaline phosphatase no greater than 1,200 U/L Coagulation tests normal Renal: Creatinine no greater than 2.5 mg/dL Other: No prior malignancy

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior intra-arterial chemotherapy for liver metastases No prior hepatic chemoembolization At least 3 months since fluorouracil

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002793

Locations
Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Sponsors and Collaborators
Klinikum der J.W. Goethe Universitaet
Investigators
Study Chair: Matthias Lorenz, MD Klinikum der J.W. Goethe Universitaet
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002793     History of Changes
Other Study ID Numbers: CDR0000064871, GER-ALM-03/95, EU-96007
Study First Received: November 1, 1999
Last Updated: September 16, 2013
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
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Liver Neoplasms
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
Liver Diseases
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

ClinicalTrials.gov processed this record on April 14, 2014