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| Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019786 |
Purpose
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 | Intervention | Phase |
|
Colorectal Cancer Islet Cell Tumor Liver Cancer Metastatic Cancer Neuroendocrine Carcinoma |
Drug: melphalan Procedure: conventional surgery Procedure: isolated perfusion |
Phase II |
| MedlinePlus related topics: | Cancer Colorectal Cancer Liver Cancer |
| Drug Information available for: | Melphalan Melphalan hydrochloride Sarcolysin |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver |
| Estimated Enrollment: | 67 |
| Study Start Date: | August 1999 |
OBJECTIVES:
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically proven liver cancer meeting 1 of the following criteria:
Metastatic cancer to the liver originating from one of the following:
Adenocarcinoma of the colon or rectum limited to parenchyma of the liver
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| NCI - Center for Cancer Research-Medical Oncology |
| National Cancer Institute (NCI) |
| Study Chair: | H. Richard Alexander, MD, FACS | NCI - Surgery Branch |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067220, NCI-99-C-0123 |
| First Received: | July 11, 2001 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00019786 |
| Health Authority: | United States: Federal Government |
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