Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00005793 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Induction Chemotherapy With Daunorubicin, Cytarabine, Topotecan and Etoposide
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT00005793: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00005793 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005793, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have previously untreated acute myeloid leukemia.
Primary Outcome
Determine the maximum tolerated dose (MTD) of topotecan when combined with daunorubicin, cytarabine, and etoposide in patients with de novo acute myeloid leukemia. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Interventions
- DRUG Etoposide
- DRUG Cytarabine
- DRUG Daunorubicin
- DRUG Topotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 1999-07 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
What the finished NCT00005793 record still lists
NCT00005793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 4 interventions - of which Etoposide is the first listed.
NCT00005793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005793 about?
NCT00005793 is a clinical study titled "A Phase I/II Study of Induction Chemotherapy With Daunorubicin, Cytarabine, Topotecan and Etoposide". RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have previously...
What is the current status of trial NCT00005793?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 1999-07. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00005793?
The interventions under investigation include: Etoposide (DRUG), Cytarabine (DRUG), Daunorubicin (DRUG), Topotecan (DRUG).
Who is sponsoring clinical trial NCT00005793?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005793's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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
- NCT03449238 · 41 participants · Phase 1
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
- NCT03900793 · 41 participants · Phase 1
Losartan + Sunitinib in Treatment of Osteosarcoma
- NCT04082520 · 41 participants · Phase 2
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
- NCT04220190 · 41 participants · Phase 2
RAPA-501 Therapy for ALS
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