Radiofrequency Ablation Followed By Hepatic Artery Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/28/2018 |
| Start Date: | August 5, 1998 |
| End Date: | December 9, 2003 |
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.
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.
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.
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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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