Radiofrequency Ablation Followed By Hepatic Artery Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

Phase II Study of Radiofrequency Ablation of Colorectal Cancer Liver Metastases Combined With Post-Ablation Hepatic Arterial Infusion of Floxuridine Alternating With 5-Fluorouracil

RATIONALE: Radiofrequency ablation may be able to shrink or destroy cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy delivered directly into the blood vessels of the liver may prevent new tumors from growing. Combining these therapies may be an effective treatment for colorectal cancer that has spread to the liver.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation followed by chemotherapy delivered directly into the blood vessels of the liver in treating patients who have colorectal cancer that has spread to the liver.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Metastatic Cancer
• Intervention / Treatment: Drug: Floxuridine; Drug: Fluorouracil (5-FU); Procedure: Conventional surgery; Procedure: Radiofrequency ablation

Detailed Description

OBJECTIVES: I. Determine the safety and efficacy of radiofrequency tissue ablation followed by hepatic arterial chemotherapy with floxuridine and fluorouracil in patients with colorectal cancer metastatic to the liver.

OUTLINE: Patients undergo an open laparotomy to identify the target tumor in the liver using intraoperative ultrasound followed by radiofrequency tissue ablation over 20 minutes to each tumor and placement of hepatic arterial catheter. Within 35 days postoperatively, patients receive hepatic arterial chemotherapy consisting of floxuridine on days 1-7 and fluorouracil over 1 hour on days 15, 22, and 29. Treatment repeats every 5 weeks for 6 courses. Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030-4009
      • University of Texas - MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer metastatic to the liver No preoperative or intraoperative evidence of extrahepatic metastasis including clinical, radiographic, gross or microscopic evidence Tumors must be no more than 4 cm in diameter No more than 6 total tumors May have failed prior systemic chemotherapy Failure of 1 prior intra-arterial regimen excluding floxuridine, fluorouracil, or another fluoropyrimidine allowed if liver enzymes recovered No evidence of cirrhosis No gross ascites

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 16 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active duodenal or gastric ulcers Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6-8 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to the liver Surgery: Not specified

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiofrequency Ablation + HAI of Floxuridine/5-FU; Radiofrequency Ablation Combined With Post-Ablation Hepatic Arterial Infusion (HAI) of Floxuridine Alternating With 5-Fluorouracil (5-FU)

Drug: Floxuridine; Part of hepatic arterial chemotherapy on days 1-7. Treatment repeats every 5 weeks for 6 courses.; Drug: Fluorouracil (5-FU); Part of hepatic arterial chemotherapy over 1 hour on days 15, 22, and 29. Treatment repeats every 5 weeks for 6 courses.; Other Names: 5-FU; 5-Fluorouracil; Adrucil; Efudex; Procedure: Conventional surgery; Open laparotomy to identify target tumor in liver using intraoperative ultrasound.; Other Names: open laparotomy; Procedure: Radiofrequency ablation; Radiofrequency tissue ablation over 20 minutes to each tumor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Tumor Response Rate	At 1 month

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Lee M. Ellis, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• UT MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 1998
• Primary Completion (Actual): December 9, 2003
• Study Completion (Actual): December 9, 2003

Study Registration Dates

• First Submitted: December 10, 1999
• First Submitted That Met QC Criteria: March 12, 2004
• First Posted (Estimate): March 15, 2004

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: stage IV rectal cancer; stage IV colon cancer; recurrent colon cancer; recurrent rectal cancer; liver metastases
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil; Floxuridine
• Other Study ID Numbers: ID98-035; P30CA016672 (U.S. NIH Grant/Contract); MDA-ID-98035 (Other Identifier: UT MD Anderson Cancer Center); NCI-G99-1616; CDR0000067373 (Registry Identifier: NCI PDQ)