Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by University of Miami. The registered enrollment target is 13 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00449137
The ClinicalTrials.gov registry entry for NCT00449137 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT00449137 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.