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NCT01525069 · ClinicalTrials.gov registry record · Phase 1
Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01525069: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT01525069 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01525069, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with locally advanced cholangiocarcinoma.
Primary Outcome
Document the frequency of grades 3-5 non-hematologic toxicities (dose-limiting toxicities) associated with the treatment regimen by patient and by type of toxicity for each cohort during the first 2 cycles of treatment
Interventions
- DRUG Oxaliplatin
- DRUG Dexamethasone
- DRUG Gemcitabine
- DRUG Floxuridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2012-04-03 |
| Est. Completion | 2022-08-02 |
| Phase | Phase 1 |
Why NCT01525069 stopped before completion
NCT01525069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Oxaliplatin is the first listed.
NCT01525069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01525069 about?
NCT01525069 is a clinical study titled "Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma". This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery. HAI is a metho...
What is the current status of trial NCT01525069?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2012-04-03. Estimated completion is 2022-08-02.
What interventions are being tested in trial NCT01525069?
The interventions under investigation include: Oxaliplatin (DRUG), Dexamethasone (DRUG), Gemcitabine (DRUG), Floxuridine (DRUG).
Who is sponsoring clinical trial NCT01525069?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01525069's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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