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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00004142

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

64.1

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Metastatic Cancer	Drug: Floxuridine Drug: Fluorouracil (5-FU) Procedure: Conventional surgery Procedure: Radiofrequency ablation	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 5, 1998

Actual Primary Completion Date :

Dec 9, 2003

Actual Study Completion Date :

Dec 9, 2003

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patient Tumor Response Rate [At 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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