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NCT00449137 · ClinicalTrials.gov registry record · Phase 1
Arsenic Trioxide, Fluorouracil, and Leucovorin in Treating Patients With Stage IV Colorectal Cancer That Has Relapsed or Not Responded to Treatment
A Phase 1 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT00449137: Completed Phase 1 study, sponsored by University of Miami.
NCT00449137 is a Phase 1 study that has completed, run by University of Miami. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00449137, a Phase 1 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide may help fluorouracil and leucovorin work better by making tumor cells more sensitive to the drugs. Giving arsenic trioxide together with fluorouracil and leucovorin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide and fluorouracil when given together with leucovorin in treating patients with stage IV colorectal cancer that has relapsed or not responded to treatment.
Primary Outcome
The objective of this phase I study is to determine a phase II dose of combination of 5-FU and ATO that can be safely used for the treatment of 5-FU resistant colon cancer. Following the dose escalation/de-escalation procedure described in section 4.2, the recommended phase II dose of the combination 5-FU with ATO will be established as the maximum tolerated dose (MTD), defined as the highest dose level combination at which \<=1 out of 6 patients experiencing DLT.
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin calcium
- DRUG Arsenic trioxide
- OTHER Plasma levels of elemental arsenic
- GENETIC Peripheral Blood Mononuclear Cells (PBMC) for mRNA analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2005-06 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
What the finished NCT00449137 record still lists
NCT00449137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT00449137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00449137 about?
NCT00449137 is a clinical study titled "Arsenic Trioxide, Fluorouracil, and Leucovorin in Treating Patients With Stage IV Colorectal Cancer That Has Relapsed or Not Responded to Treatment". RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide may help fluorouracil and leucovorin work better by making tumor cells more sensitive ...
What is the current status of trial NCT00449137?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2005-06. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00449137?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin calcium (DRUG), Arsenic trioxide (DRUG), Plasma levels of elemental arsenic (OTHER), Peripheral Blood Mononuclear Cells (PBMC) for mRNA analysis (GENETIC).
Who is sponsoring clinical trial NCT00449137?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00449137's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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