Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 1 study, sponsored by Duke University.
NCT00346229 is a Phase 1 study that was terminated before completion, run by Duke University. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00346229 stopped before completion
NCT00346229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 4 interventions - of which filgrastim is the first listed.
NCT00346229 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00346229's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02429557 · 29 participants · Phase 1
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
- NCT02568878 · 29 participants · Phase 3
Creatine for Depressed Male and Female Methamphetamine Users
- NCT03014401 · 29 participants · NA
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
- NCT03128996 · 29 participants · Phase 1
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia