Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
|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
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|