At a glance
ClinicalIndex Comparison RecordPhase 1Completed
Drug / intervention
Melphalan +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Melphalan, Floxuridine, and 1 other intervention for Colorectal Neoplasm and 2 related conditions. Completed, across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasm, Liver Neoplasm, Neoplasm Metastasis
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 1997
First PostedNov 1999
Study CompletionMar 2002
TodayJul 2026
First PostedNov 4, 1999
Enrollment StartJul 1, 1997
Study CompletionMar 1, 2002
TodayJul 2, 2026
Posted 26.7 years ago
Interventions
Melphalandrug
Floxuridinedrug
Leucovorindrug