Isolated Hepatic Perfusion With Melphalan Followed By Chemotherapy in Treating Patients With Unresectable Colorectal Cancer That is Metastatic 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.|
|ClinicalTrials.gov Identifier: NCT00019760|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : March 23, 2012
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 and giving them in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of melphalan given as an isolated hepatic perfusion followed by chemotherapy infused into the liver in patients who have unresectable colorectal cancer that is metastatic to the liver.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Colon Cancer Liver Metastases Stage IV Rectal Cancer Recurrent Rectal Cancer Stage IV Colon Cancer||Drug: floxuridine Drug: leucovorin calcium Drug: melphalan||Phase 2|
OBJECTIVES: I. Determine the response rate and response duration in patients with unresectable colorectal cancer metastatic to the liver treated with isolated hepatic perfusion with melphalan followed by postoperative hepatic arterial chemotherapy.
II. Determine the patterns of recurrence in this patient population with this treatment regimen.
III. Evaluate the disease-free survival and overall survival in these patients.
IV. Evaluate health related quality of life and determine whether baseline correlates with the length of survival.
PROTOCOL OUTLINE: Patients undergo surgery and hyperthermic isolated hepatic perfusion with melphalan given intra-arterially over 60 minutes.
At six weeks post-hepatic perfusion, patients receive floxuridine and leucovorin calcium intra-arterially as a continuous infusion over 14 days. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to study and then at each followup visit. Patients are followed every 3-4 months for 3 years and then every 6 months thereafter or until disease progression.
A total of 50 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Isolated Hepatic Perfusion With Melphalan Followed By Postoperative Hepatic Arterial Chemotherapy in Patients With Unresectable Colorectal Cancer Metastatic to the Liver|
|Study Start Date :||April 1999|
|Study Completion Date :||March 2002|
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 ClinicalTrials.gov identifier (NCT number): NCT00019760
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||H. Richard Alexander, Jr.||National Cancer Institute (NCI)|