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

M.D. Anderson Cancer Center40 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

FloxuridineDRUG

Part of hepatic arterial chemotherapy on days 1-7. Treatment repeats every 5 weeks for 6 courses.

Fluorouracil (5-FU)DRUG

Part of hepatic arterial chemotherapy over 1 hour on days 15, 22, and 29. Treatment repeats every 5 weeks for 6 courses.

Conventional surgeryPROCEDURE

Open laparotomy to identify target tumor in liver using intraoperative ultrasound.

Radiofrequency ablationPROCEDURE

Radiofrequency tissue ablation over 20 minutes to each tumor.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes