Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Ca… (NCT00019786) | Clinical Trial Compass
CompletedPhase 2
Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
United States67 participantsStarted 1999-08
Plain-language summary
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.
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 obstru…
What they're measuring
1
Response rate
2
Duration of response
3
Patterns of recurrence
4
Disease-free survival
5
Overall survival
Trial details
NCT IDNCT00019786
SponsorNational Institutes of Health Clinical Center (CC)