Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
|ClinicalTrials.gov 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
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|
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)|
|Official Title:||Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV|
|Study Start Date :||January 1999|
Please refer to this study by its ClinicalTrials.gov 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|
|Study Chair:||Michel Ducreux, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|