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

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ClinicalTrials.gov Identifier: NCT00019786
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 23, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date  ICMJE July 11, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date March 23, 2012
Study Start Date  ICMJE August 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
  • Response rate
  • Duration of response
  • Patterns of recurrence
  • Disease-free survival
  • Overall survival
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00019786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
Official Title  ICMJE A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver
Brief 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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Islet Cell Tumor
  • Liver Cancer
  • Metastatic Cancer
  • Neuroendocrine Carcinoma
Intervention  ICMJE
  • Drug: isolated perfusion
  • Drug: melphalan
  • Procedure: conventional surgery
Study Arms  ICMJE Not Provided
Publications * Feldman AL, Libutti SK, Pingpank JF, Bartlett DL, Beresnev TH, Mavroukakis SM, Steinberg SM, Liewehr DJ, Kleiner DE, Alexander HR. Analysis of factors associated with outcome in patients with malignant peritoneal mesothelioma undergoing surgical debulking and intraperitoneal chemotherapy. J Clin Oncol. 2003 Dec 15;21(24):4560-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 3, 2007)
67
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00019786
Other Study ID Numbers  ICMJE 990123
99-C-0123
CDR0000067220
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institutes of Health Clinical Center (CC)
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: H. Richard Alexander, MD, FACS NCI - Surgery Branch
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP