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Phase II Study of Isolated Hepatic Perfusion With Melphalan Followed By Postoperative Hepatic Arterial Chemotherapy in Patients With Unresectable Colorectal Cancer Metastatic to the Liver

Phase 2
Not Enrolling
Recurrent Colon Cancer, Liver Metastases, Stage IV Rectal Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer

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Trial Information

Phase II Study of Isolated Hepatic Perfusion With Melphalan Followed By Postoperative Hepatic Arterial Chemotherapy in Patients With Unresectable Colorectal Cancer Metastatic to the Liver

OBJECTIVES: I. Determine the response rate and response duration in patients with
unresectable colorectal cancer metastatic to the liver treated with isolated hepatic
perfusion with melphalan followed by postoperative hepatic arterial chemotherapy.

II. Determine the patterns of recurrence in this patient population with this treatment

III. Evaluate the disease-free survival and overall survival in these patients.

IV. Evaluate health related quality of life and determine whether baseline correlates with
the length of survival.

PROTOCOL OUTLINE: Patients undergo surgery and hyperthermic isolated hepatic perfusion with
melphalan given intra-arterially over 60 minutes.

At six weeks post-hepatic perfusion, patients receive floxuridine and leucovorin calcium
intra-arterially as a continuous infusion over 14 days. Treatment repeats every 28 days in
the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to study and then at each followup visit. Patients are
followed every 3-4 months for 3 years and then every 6 months thereafter or until disease


A total of 50 patients will be accrued for this study.

Inclusion Criteria


--Disease Characteristics-- Histologically or cytologically proven measurable metastatic
colorectal cancer limited to the parenchyma of the liver No evidence of unresectable
extrahepatic disease Limited resectable extrahepatic disease allowed Unresectable liver
disease defined as: Greater than 3 sites of liver disease OR Bilobar disease OR Tumor
abutting major vascular or ductal structures, impeding resection with preservation of
liver function OR Limited extrahepatic disease No biopsy-proven cirrhosis No significant
portal hypertension --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since
prior biologic therapy for colorectal cancer and recovered Chemotherapy: At least 4 weeks
since prior chemotherapy for colorectal cancer and recovered No prior intrahepatic
arterial infusional therapy using floxuridine Endocrine therapy: Not specified
Radiotherapy: At least 4 weeks since prior radiotherapy for colorectal cancer and
recovered Surgery: See Disease Characteristics Other: No concurrent immunosuppressive
drugs No concurrent chronic anticoagulants --Patient Characteristics-- Age: Not specified
Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count
greater than 100,000/mm3 Hematocrit greater than 27.0% WBC greater than 3,000/mm3 Hepatic:
Bilirubin less than 2.0 mg/dL PT no greater than 2 seconds over upper limit of normal
Elevated hepatic transaminases secondary to liver metastases allowed No veno-occlusive
disease Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than
60 mL/min Cardiovascular: No congestive heart failure with LVEF less than 40% Pulmonary:
No chronic obstructive pulmonary disease No other chronic pulmonary disease with pulmonary
function test less than 50% predicted Other: No active infections HIV negative Body weight
greater than 30 kg Not pregnant or nursing Negative pregnancy test

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

H. Richard Alexander, Jr.

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

March 2002

Related Keywords:

  • Recurrent Colon Cancer
  • Liver Metastases
  • Stage IV Rectal Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • adult solid tumor
  • body system/site cancer
  • cancer
  • colon cancer
  • colorectal cancer
  • gastrointestinal cancer
  • genetic condition
  • liver and intrahepatic biliary tract cancer
  • liver metastases
  • metastatic cancer
  • rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • site, metastatic cancer
  • solid tumor
  • stage IV colon cancer
  • stage IV rectal cancer
  • stage, colon cancer
  • stage, rectal cancer
  • unclassified/other cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms



Surgery Branch Bethesda, Maryland  20892