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Hepatic Arterial Infusion of Oxaliplatin Clinical Trial

Phase 1/Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer, Metastasis, Liver Cancer

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Trial Information

Hepatic Arterial Infusion of Oxaliplatin Clinical Trial

After entry qualification and registration patients will undergo hepatic artery
catheterization via interventional radiology. The catheter will remain in place for two
hours while oxaliplatin is infused and then be removed. This treatment will be followed by a
48 hour infusion of 5FU and leucovorin, generally following the principle of FOLFOX 6. These
cycles of therapy will be repeated biweekly for six episodes. Hepatic tumor size will be
evaluated by CT scan to determine if resectability has been established as the result of
tumor size reduction. If so, the patient will be offered resection of the residual lesions
in an effort to achieve long term survival.

Inclusion Criteria:

1. Signed consent

2. Age greater than 17 years

3. Stage IV colorectal cancer

4. Metastasis limited to the liver considered unresectable for cure by standard methods

5. Completely resected primary tumor

6. Life expectancy greater than 3 years excluding cancer

7. Eastern Cooperative Oncology Group (ECOG) status 0, 1, 2

8. Absolute granulocyte count greater than 1500

9. Platelet count greater than 100,000

10. Adequate hepatic function

11. Adequate renal function

Exclusion Criteria:

1. Concomitant anticancer therapy other than this protocol

2. Gastroduodenal ulcer

3. Pregnancy or lactation

4. Last treatment for colon cancer less than 4 weeks from this protocol

Type of Study:


Study Design:

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

Outcome Measure:

number of patients who become eligible for total resection of metastatic liver tumor

Principal Investigator

Robert K Ausman, M. D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. Surgery, Medical College of Wisconsin


United States: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

December 2007

Related Keywords:

  • Colorectal Cancer
  • Metastasis
  • Liver Cancer
  • hepatic artery infusion
  • colorectal cancer
  • liver metastasis
  • oxaliplatin
  • 5 fluorouracil
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis



Medical College of Wisconsin/ Froedtert Hospital Milwaukee, Wisconsin  53226