A Phase I Study of Isolated Hepatic Perfusion With Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver
Completed · Phase 1
Conditions studied: Colorectal Neoplasm, Liver Neoplasm, Neoplasm Metastasis
In brief
Patients with unresectable metastatic colorectal cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) with escalating dose melphalan. Postoperatively, patients will be treated with hepatic arterial infusion of floxuridine (FUDR), 0.2 mg/kg/day and leucovorin (LV), 15 mg/M2/day as a 2-week continuous infusion regimen. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed.
Key facts
- Study ID
- NCT00001576
- Run by
- National Cancer Institute (NCI)
- People needed
- 28
- Starts
- 1997-07-01
- Expected to finish
- 2002-03-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- National Cancer Institute (NCI) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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