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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Information provided by: National Cancer Institute (NCI)


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 Treatment or Intervention Phase
recurrent colon cancer
liver metastases
Stage IV rectal cancer
recurrent rectal cancer
stage IV colon cancer
 Drug: floxuridine
 Drug: fluorouracil
Phase II

MedlinePlus related topics:  Colorectal Cancer;   Liver Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Radiofrequency Interstitial Ablation Followed By Hepatic Arterial Chemotherapy With Floxuridine and Fluorouracil in Patients With Colorectal Cancer Metastatic to the Liver

Further Study Details: 

Study start: September 1999

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.

PROTOCOL 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.


Ages Eligible for Study:  18 Years and above



--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

--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

--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

Location Information

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

Study chairs or principal investigators

Lee M. Ellis,  Study Chair,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067373; MDA-ID-98035; NCI-G99-1616
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999 Identifier:  NCT00004142
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005