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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006050
Recruitment Status : Unknown
Verified September 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 2, 2004
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Drug: FOLFOX regimen Drug: fluorouracil Drug: isolated perfusion Drug: leucovorin calcium Drug: oxaliplatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV
Study Start Date : January 1999

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006050

Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Study Chair: Michel Ducreux, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris

Publications of Results: Identifier: NCT00006050     History of Changes
Other Study ID Numbers: CDR0000068072
First Posted: February 2, 2004    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: September 2005

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
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
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Protective Agents
Vitamin B Complex