Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
|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: NCT00019786|
Recruitment Status : Completed
First Posted : January 27, 2003
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. Giving 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 primary unresectable liver cancer or liver metastases.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Islet Cell Tumor Liver Cancer Metastatic Cancer Neuroendocrine Carcinoma||Drug: isolated perfusion Drug: melphalan Procedure: conventional surgery||Phase 2|
- Determine response rate, duration of response, and patterns of recurrence in patients with primary or metastatic, unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases, or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan. Liver perfusion proceeds for 1 hour.
Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until disease progression.
PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver|
|Study Start Date :||August 1999|
|Actual Study Completion Date :||January 2006|
- Response rate
- Duration of response
- Patterns of recurrence
- Disease-free survival
- Overall survival
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): NCT00019786
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||H. Richard Alexander, MD, FACS||NCI - Surgery Branch|