Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized 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: NCT00089401|
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : May 14, 2012
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with unresectable colorectal cancer that has metastasized to the liver.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Cancer||Drug: isolated perfusion Drug: melphalan Procedure: conventional surgery||Phase 2|
- Determine the response and duration of response in patients with unresectable colorectal cancer metastatic to the liver and refractory to first-line systemic chemotherapy treated with isolated hepatic perfusion with melphalan.
- Determine the pattern of recurrence (liver vs systemic) in patients treated with this regimen.
- Determine hepatic progression-free and overall survival in patients treated with this regimen.
- Determine the time to hepatic and systemic progression in patients treated with this regimen.
- Determine quality of life (QOL) in patients treated with this regimen.
- Correlate baseline QOL with length of survival in patients treated with this regimen.
OUTLINE: Patients undergo a limited laparotomy to determine if extrahepatic disease that was not visualized during preoperative scanning is present. Patients found to have peritoneal seeding or unresectable extrahepatic metastatic disease not previously visualized on scans do not receive isolated hepatic perfusion (IHP). Remaining patients undergo IHP with melphalan and hyperthermia therapy. Liver perfusion continues for 1 hour.
Quality of life is assessed at baseline, 6 weeks, and then every 3-4 months for 3 years.
Patients are followed at 6 weeks, every 3-4 months for 3 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Of Isolated Hepatic Perfusion (IHP) With Melphalan For Subjects With Metastatic Unresectable Colorectal Cancers Of The Liver With Disease Refractory To First Line Systemic Chemotherapy|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||March 2008|
- Duration of response
- Patterns of tumor recurrence (liver vs systemic)
- Progression-free survival
- Overall survival
- Quality of life
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): NCT00089401
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Steven K. Libutti, MD||NCI - Surgery Branch|