Floxuridine, Dexamethasone, and Irinotecan After Surgery in Treating Patients With Liver Metastases From Colorectal Cancer - Article Fluorodeoxyuridine; FUDR
Clinical Trial: Floxuridine, Dexamethasone, and Irinotecan After Surgery in Treating Patients With Liver Metastases From Colorectal Cancer
This study has been completed.
RATIONALE: Drugs used in chemotherapy, such as floxuridine, dexamethasone, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery.
PURPOSE: Phase II trial to study the effectiveness of irinotecan combined with hepatic arterial infusion with floxuridine and dexamethasone after surgery in treating patients who have liver metastases from colorectal cancer.
|Condition||Treatment or Intervention||Phase|
|Colon Cancer |
| Drug: dexamethasone |
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: hepatic arterial infusion
|Phase II |
MedlinePlus related topics: Colorectal Cancer; Liver Cancer
Study Type: Interventional
Study Design: Treatment
- Determine the maximum tolerated dose (MTD) of hepatic arterial infusion of floxuridine (FUDR) and dexamethasone given via an implanted pump in combination with weekly intravenous irinotecan as adjuvant treatment after resection of hepatic metastases in patients with hepatic metastases from colorectal cancer. (The MTDs of irinotecan and floxuridine have been reached as of 10/15/03; phase I closed to accrual as of 10/15/03.)
- Determine the efficacy of this combination chemotherapy after liver resection, in terms of 2-year survival and 2-year recurrence rates, in these patients.
- Determine the pharmacokinetic effects of intrahepatic FUDR and liver resection on the metabolism of irinotecan to its active metabolite, SN-38 in these patients.
- Determine the safety and efficacy of the pump used in delivering intra-arterial chemotherapy to the liver in these patients.
OUTLINE: This is a dose-escalation* study of floxuridine and irinotecan.
Patients undergo hepatic resection and pump placement into the abdomen. About 4 weeks after surgery, patients receive irinotecan IV over 30 minutes on days 1 and 15. Patients also receive floxuridine and dexamethasone intra-arterially via an implanted pump continuously on days 1-14. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or disease progression.
Sequential dose escalation of irinotecan is followed by sequential dose escalation of floxuridine. Cohorts of 3-6 patients receive escalating doses of irinotecan and floxuridine until the maximum tolerated doses (MTDs) are determined. The MTD* (phase II dose) is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years, every 4 months for 2-4 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 2-24 patients will be accrued for the phase I portion of this study within 1 year (phase I closed to accrual as of 10/15/03). A total of 50 additional patients will be accrued for this study at the phase II dose level.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- Histologically confirmed colorectal adenocarcinoma
- Primary colorectal tumor must have been previously resected
- Potentially completely resectable hepatic metastases (or removable by cryoresection) without current evidence of other metastatic disease
- No extrahepatic sites of disease
- No ascites or hepatic encephalopathy
PATIENT CHARACTERISTICS: Age:
- 18 and over
- Karnofsky 60-100%
- Not specified
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- Not specified
- Not pregnant or nursing
- No active infection
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Not specified
- At least 4 weeks since prior chemotherapy
- Not specified
- See Disease Characteristics
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States
Nancy E. Kemeny, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003753
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005