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Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

This study is ongoing, but not recruiting participants.

Sponsored by: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006050
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: isolated perfusion
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

Drug Information available for:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Fluorouracil    Oxaliplatin    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV

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

Study Start Date:   January 1999

Detailed Description:

OBJECTIVES: I. Determine the efficacy and tolerance of oxaliplatin by hepatic perfusion combined with intravenous leucovorin calcium and fluorouracil in patients with liver metastases from colorectal cancer.

OUTLINE: Patients receive oxaliplatin by hepatic perfusion over 2 hours on day 1 plus leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. If a good response is achieved after 8 courses of chemotherapy, patients may undergo surgical resection of metastases.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven colorectal cancer metastatic to the liver Unresectable disease Less than 50% invasion of the liver Measurable disease No prior irradiation Largest diameter at least 20 mm No detectable extrahepatic disease

PATIENT CHARACTERISTICS: Age: Under 75 Performance status: WHO 0-2 Life expectancy: Greater than 2 months Hematopoietic: WBC at least 4,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 35 micromoles/L Renal: Creatinine less than 130 micromoles/L Cardiovascular: No severe cardiac insufficiency Pulmonary: No respiratory disease that would preclude study Other: No other serious illness that would preclude study No psychological illness that would preclude study No peripheral neuropathy No prior malignancy not considered cured Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior intravenous oxaliplatin No more than 1 prior regimen of intravenous chemotherapy for metastatic disease Primary chemotherapy of fluorouracil allowed if stable or progressive disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006050

Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle    
      Montpellier, France, 34298
Institut Gustave Roussy    
      Villejuif, France, F-94805
Institut J. Paoli and I. Calmettes    
      Marseille, France, 13273

Sponsors and Collaborators
Federation Nationale des Centres de Lutte Contre le Cancer

Investigators
Study Chair:     Michel Ducreux, MD, PhD     Institut Gustave Roussy    
  More Information


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

Publications of Results:

Study ID Numbers:   CDR0000068072, FRE-FNCLCC-98012-PAC-ACCORD-04, EU-20017
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006050
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer  
stage IV rectal cancer  
liver metastases  

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Neoplasm Metastasis
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Vitamin B Complex
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on December 03, 2008




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