We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized to the Liver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00089401
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : May 14, 2012
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy 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 unresectable colorectal cancer that has metastasized to the liver.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Drug: isolated perfusion Drug: melphalan Procedure: conventional surgery Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Determine the response and duration of response in patients with unresectable colorectal cancer metastatic to the liver and refractory to first-line systemic chemotherapy treated with isolated hepatic perfusion with melphalan.

Secondary

  • Determine the pattern of recurrence (liver vs systemic) in patients treated with this regimen.
  • Determine hepatic progression-free and overall survival in patients treated with this regimen.
  • Determine the time to hepatic and systemic progression in patients treated with this regimen.
  • Determine quality of life (QOL) in patients treated with this regimen.
  • Correlate baseline QOL with length of survival in patients treated with this regimen.

OUTLINE: Patients undergo a limited laparotomy to determine if extrahepatic disease that was not visualized during preoperative scanning is present. Patients found to have peritoneal seeding or unresectable extrahepatic metastatic disease not previously visualized on scans do not receive isolated hepatic perfusion (IHP). Remaining patients undergo IHP with melphalan and hyperthermia therapy. Liver perfusion continues for 1 hour.

Quality of life is assessed at baseline, 6 weeks, and then every 3-4 months for 3 years.

Patients are followed at 6 weeks, every 3-4 months for 3 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Isolated Hepatic Perfusion (IHP) With Melphalan For Subjects With Metastatic Unresectable Colorectal Cancers Of The Liver With Disease Refractory To First Line Systemic Chemotherapy
Study Start Date : July 2004
Primary Completion Date : November 2006
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Response
  2. Duration of response

Secondary Outcome Measures :
  1. Patterns of tumor recurrence (liver vs systemic)
  2. Progression-free survival
  3. Overall survival
  4. Quality of life

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed colorectal cancer

    • Metastatic disease limited to the parenchyma of the liver

      • Patients with limited sites of extrahepatic disease AND who have dominant life-limiting disease in the liver are considered eligible provided the extrahepatic sites can be treated with local ablative measures (e.g., resection or external beam radiotherapy)
      • No other evidence of unresectable extrahepatic disease by radiological studies
  • Unresectable hepatic disease defined by > 3 sites of disease in the liver, bilobar disease, or tumor abutting major vascular or ductal structures making anatomic resection with liver function preservation impossible
  • Measurable disease
  • Refractory to prior first-line systemic chemotherapy

    • Disease progression during or after completion of treatment with an irinotecan- or oxaliplatin-containing regimen for established hepatic metastases

      • Treatment failure is defined as disease progression evidenced by tumor growth OR new lesions on imaging modalities OR increasing carcinoembryonic antigen (CEA)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Hematocrit > 27.0%
  • Platelet count > 100,000/mm^3
  • WBC > 3,000/mm^3

Hepatic

  • Bilirubin < 2.0 mg/dL
  • PT ≤ 2 seconds of the upper limit of normal
  • ALT and AST elevations secondary to metastatic disease allowed
  • Chronic active hepatitis B or C allowed provided there is no evidence of cirrhosis on pathology, radiologic studies, or physical exam
  • No history of veno-occlusive disease
  • No biopsy proven cirrhosis
  • No evidence of significant portal hypertension manifested by ascites, esophageal varices on endoscopy, or radiologic studies showing significant collateral vessels around the organs drained by the portal venous system
  • No other liver condition that would preclude study therapy

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • LVEF ≥ 40%
  • No ischemic cardiac disease
  • No history of congestive heart failure

Pulmonary

  • Chronic obstructive pulmonary disease or other chronic pulmonary disease allowed provided pulmonary function test ≥ 50% of predicted

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • No active infection
  • Weight > 30 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior biologic therapy for the malignancy and recovered

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy for the malignancy and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy for the malignancy and recovered

Surgery

  • See Disease Characteristics

Other

  • No concurrent immunosuppressive drugs
  • No concurrent chronic anticoagulation therapy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089401


Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
Study Chair: Steven K. Libutti, MD NCI - Surgery Branch
More Information

ClinicalTrials.gov Identifier: NCT00089401     History of Changes
Obsolete Identifiers: NCT00086697
Other Study ID Numbers: 040229
04-C-0229
CDR0000378323
First Posted: August 5, 2004    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs