Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
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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: isolated perfusion Drug: melphalan Procedure: conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver |
- Response rate [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Patterns of recurrence [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 67 |
| Study Start Date: | August 1999 |
| Study Completion Date: | January 2006 |
OBJECTIVES:
- 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically proven liver cancer meeting 1 of the following criteria:
- Primary unresectable hepatocellular or cholangiocellular carcinoma
Metastatic cancer to the liver originating from one of the following:
- Intraocular melanoma (closed to accrual as of 10/17/03)
- Islet cell carcinoma
Adenocarcinoma of the colon or rectum limited to parenchyma of the liver
- No evidence of other unresectable extrahepatic colorectal metastasis
- Other neuroendocrine tumors, such as carcinoid tumors
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Hematocrit greater than 27.0%
- WBC at least 2,500/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
- PT no greater than 2 seconds above upper limit of normal
- Elevated SGOT and SGPT allowed if not due to hepatitis
- No biopsy-proven cirrhosis or evidence of significant portal hypertension
- No prior or concurrent veno-occlusive disease
- Patients with positive hepatitis B or C surface antigen serology and chronic active hepatitis are eligible provided there is no evidence of cirrhosis
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- Congestive heart failure allowed if LVEF ≥ 40%
Pulmonary:
- No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age
Other:
- Weight greater than 30 kg
- Not pregnant or nursing
- Negative pregnancy test
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 month since prior anticancer biologic therapy and recovered
Chemotherapy:
- At least 1 month since prior anticancer chemotherapy and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 1 month since prior anticancer radiotherapy and recovered
Surgery:
- Not specified
Other:
- Prior intrahepatic arterial infusion therapy allowed
- No chronic use of anticoagulants
- No concurrent immunosuppressive therapy
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00019786 History of Changes |
| Obsolete Identifiers: | NCT00001820 |
| Other Study ID Numbers: | 990123, 99-C-0123, CDR0000067220 |
| Study First Received: | July 11, 2001 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer recurrent islet cell carcinoma adult primary hepatocellular carcinoma adenocarcinoma of the colon |
adenocarcinoma of the rectum liver metastases adult primary cholangiocellular carcinoma advanced adult primary liver cancer recurrent childhood liver cancer childhood hepatocellular carcinoma stage III childhood liver cancer stage IV childhood liver cancer neuroendocrine carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Colorectal Neoplasms Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Carcinoma, Neuroendocrine Adenoma, Islet Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Liver Diseases Neoplastic Processes Pathologic Processes Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue Adenoma Pancreatic Neoplasms Endocrine Gland Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013