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NCT00001576 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00001576: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001576 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001576, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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.
Interventions
- DRUG Melphalan
- DRUG Leucovorin
- DRUG Floxuridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 1997-07 |
| Est. Completion | 2002-03 |
| Phase | Phase 1 |
What the finished NCT00001576 record still lists
NCT00001576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Melphalan is the first listed.
NCT00001576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001576 about?
NCT00001576 is a clinical study titled "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". 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 leucovor...
What is the current status of trial NCT00001576?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 1997-07. Estimated completion is 2002-03.
What interventions are being tested in trial NCT00001576?
The interventions under investigation include: Melphalan (DRUG), Leucovorin (DRUG), Floxuridine (DRUG).
Who is sponsoring clinical trial NCT00001576?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001576's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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