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A Phase I Trial of Isolated Hepatic Perfusion With Oxaliplatin Followed by Hepatic Arterial Infusion of FUDR and Leucovorin for Patients With Unresectable Colorectal Liver Metastases

Phase 1
18 Years
Not Enrolling
Unresectable Colorectal Liver Metastases

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Trial Information

A Phase I Trial of Isolated Hepatic Perfusion With Oxaliplatin Followed by Hepatic Arterial Infusion of FUDR and Leucovorin for Patients With Unresectable Colorectal Liver Metastases

Inclusion Criteria:

- Patients will be included that are scheduled to undergo surgery for placement of
hepatic arterial infusion pump for HAI therapy and

- Histologically or cytologically proven measurable metastatic colorectal cancer
limited to the parenchyma of the liver with no evidence of unresectable extrahepatic
disease by preoperative radiological studies. Limited resectable extrahepatic
disease is acceptable.

- No chemotherapy, radiotherapy, or biologic therapy for their malignancy in the 4
weeks prior to the liver perfusion and must have recovered from all side effects.

- An ECOG performance standard of 0, 1 or 2 for 24 hours prior to surgery.

- Adequate hepatic function as evidenced by bilirubin < 2.0 mg/dL and a PT < 2 seconds
greater than the upper limit of normal.

- Age equal to 18 years or older and greater than 30 kg.

- Platelet counts greater than 100,000, a hematocrit > 27.0, a white blood count >
3000/microliter, and a creatinine less than or equal to 1.5 mg/dL or a creatinine
clearance of > 60 mL/min. Patients with elevations in hepatic transaminases
secondary to the presence of metastatic disease in the liver are eligible.

- Aware of the neoplastic nature of his/her illness, the experimental nature of the
therapy, alternative treatments, potential benefits, and risks and willing to sign an
informed consent.

- The disease in the liver must be considered unresectable as defined by greater than
three sites of disease in the liver, bilobar disease, and tumor abutting major
vascular or ductal structures making anatomic resection with preservation of liver
function impossible.

Exclusion Criteria:

- Pregnant patients and nursing mothers will be excluded due to the unknown effects of
oxaliplatin on the fetus or newborn

- Patients taking immunosuppressive drugs or on chronic anticoagulation will not be

- Patients with active infections are not eligible.

- Patients with biopsy proven cirrhosis or 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
will be excluded.

- Patients with ischemic cardiac disease or history of congestive heart failure with an
LVEF < 40% will be excluded.

- Patients with COPD or other chronic pulmonary disease with PFT's indicating an FEV<
50% predicted for age will be excluded.

- Patients with a history of veno-occlusive disease of the liver are ineligible.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose and dose limiting toxicity of oxaliplatin delivered via isolated hepatic perfusion (IHP).

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

David L Bartlett, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

May 2003

Completion Date:

November 2011

Related Keywords:

  • Unresectable Colorectal Liver Metastases
  • Neoplasm Metastasis
  • Liver Neoplasms



UPMC PresbyterianPittsburgh, Pennsylvania  15213
UPMC ShadysidePittsburgh, Pennsylvania  15232
UPMC Cancer Centers, Hillman Cancer CenterPittsburgh, Pennsylvania  15232