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NCT00346229 · ClinicalTrials.gov registry record · Phase 1
Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer
A Phase 1 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT00346229 is a Phase 1 study that was terminated before completion, run by Duke University. The registered enrollment target is 29 participants.
The verdict
NCT00346229, a Phase 1 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Giving temperature-sensitive liposomal doxorubicin together with hyperthermia may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of temperature-sensitive liposomal doxorubicin when given together with hyperthermia in treating women with locally recurrent breast cancer.
Interventions
- BIOLOGICAL filgrastim
- BIOLOGICAL pegfilgrastim
- PROCEDURE hyperthermia treatment
- DRUG lyso-thermosensitive liposomal doxorubicin(Thermodox)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2006-04 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00346229
The ClinicalTrials.gov registry entry for NCT00346229 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which filgrastim is the first listed.
NCT00346229 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00346229 about?
NCT00346229 is a clinical study titled "Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Givi...
What is the current status of trial NCT00346229?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2006-04. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00346229?
The interventions under investigation include: filgrastim (BIOLOGICAL), pegfilgrastim (BIOLOGICAL), hyperthermia treatment (PROCEDURE), lyso-thermosensitive liposomal doxorubicin(Thermodox) (DRUG).
Who is sponsoring clinical trial NCT00346229?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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