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Hepatic Artery Infusion With Oxaliplatin

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ClinicalTrials.gov Identifier: NCT00244348
Recruitment Status : Withdrawn (Investigator has left institution)
First Posted : October 26, 2005
Last Update Posted : August 27, 2015
Sponsor:
Information provided by:
Medical College of Wisconsin

Brief Summary:
Hepatic artery infusion (HAI) with oxaliplatin (OX), systemic 5 fluorouracil (5FU), and leucovorin (HAI/OX/FU) will be implemented using an interventional radiology technique to obviate the need for initial major surgery (catheter placement) in patients who have unresectable liver metastasis from colorectal cancer. The study goal is to reduce tumor size to make possible a complete resection of all lesions. Secondary goals are to reduce or eliminate the complexity usually associated with HAI, to accomplish most or all of the treatment as an outpatient, to reduce costs, and to avoid the hepatotoxicity associated with HAI/floxuridine (FUDR). Oxaliplatin has been selected because of its ease of use, known toxicology, and established efficacy in colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastasis Liver Cancer Drug: Oxaliplatin (via HAI) Drug: 5 Fluorouracil (systemic) Phase 1 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Arterial Infusion of Oxaliplatin Clinical Trial
Study Start Date : October 2005
Estimated Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. number of patients who become eligible for total resection of metastatic liver tumor
  2. overall survival of patients resected for cure versus (vs.) resected for palliation vs. not resected.

Secondary Outcome Measures :
  1. toxicity
  2. HAI complexity
  3. cost


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

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

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): NCT00244348


Locations
United States, Wisconsin
Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Robert K Ausman, M. D. Dept. Surgery, Medical College of Wisconsin
Principal Investigator: Edward J Quebbeman, M. D. Dept. Surgery, Medical College of Wisconsin
Principal Investigator: William S Rilling, M. D. Dept. Radiology, Medical College of Wisconsin

ClinicalTrials.gov Identifier: NCT00244348     History of Changes
Other Study ID Numbers: HRRC#341-05
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015

Keywords provided by Medical College of Wisconsin:
hepatic artery infusion
colorectal cancer
liver metastasis
oxaliplatin
5 fluorouracil

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
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
Liver Diseases
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs