Hepatic Artery Infusion With Oxaliplatin

NCT00244348 | Withdrawn Phase 1

• 1 other identifier: HRRC#341-05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Metastasis; Liver Cancer

Keywords

hepatic artery infusion; colorectal cancer; liver metastasis; oxaliplatin; 5 fluorouracil

Outcome Measures

Primary Outcomes (2)

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

• overall survival of patients resected for cure versus (vs.) resected for palliation vs. not resected.

Secondary Outcomes (3)

• toxicity

• HAI complexity

• cost

Interventions

Oxaliplatin (via HAI) DRUG

5 Fluorouracil (systemic) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed consent
• Age greater than 17 years
• Stage IV colorectal cancer
• Metastasis limited to the liver considered unresectable for cure by standard methods
• Completely resected primary tumor
• Life expectancy greater than 3 years excluding cancer
• Eastern Cooperative Oncology Group (ECOG) status 0, 1, 2
• Absolute granulocyte count greater than 1500
• Platelet count greater than 100,000
• Adequate hepatic function
• Adequate renal function

You may not qualify if:

• Concomitant anticancer therapy other than this protocol
• Gastroduodenal ulcer
• Pregnancy or lactation
• Last treatment for colon cancer less than 4 weeks from this protocol

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin/ Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms

Interventions

Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 26, 2005
• Study Start: October 1, 2005
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

US (1)