Phase II Study of Radiofrequency Ablation of Colorectal Cancer Liver Metastases Combined With Post-Ablation Hepatic Arterial Infusion of Floxuridine Alternating With 5-Fluorouracil
18 Years
N/A
Both
Colorectal Cancer, Metastatic Cancer
Trial Information
Phase II Study of Radiofrequency Ablation of Colorectal Cancer Liver Metastases Combined With Post-Ablation Hepatic Arterial Infusion of Floxuridine Alternating With 5-Fluorouracil
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Patient Tumor Response Rate
Outcome Time Frame:
At 1 month
Safety Issue:
Yes
Principal Investigator
Lee M. Ellis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
ID98-035
NCT ID:
NCT00004142
Start Date:
September 1999
Completion Date:
December 2003
Related Keywords:
- Colorectal Cancer
- Metastatic Cancer
- stage IV colon cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- liver metastases
- Colorectal Neoplasms
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
