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NCT00479089 · ClinicalTrials.gov registry record · Phase 2
Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00479089: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00479089 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00479089, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Primary Objective: 1\. To compare the proportion of patients free from progression 9 months from the start of consolidation therapy with the combination of docetaxel and ZD1839 (Iressa) versus docetaxel alone. For the purposes of this protocol, "consolidation" therapy refers to treatment given at the time of maximal benefit from conventional front-line multi-agent chemotherapy. Secondary Objective: 1\. To compare time to progression (TTP), overall survival (OS) and cause-specific survival (CSS) in the two arms. For completeness, these will be reported both from the initiation of consolidation chemotherapy, and from the completion of induction chemotherapy.
Primary Outcome
The proportion of participants' progression free at 9 months compared between treatments using chi-square. Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was
Interventions
- DRUG Docetaxel
- DRUG Dexamethasone
- DRUG ZD1839
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-02 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
Why NCT00479089 stopped before completion
NCT00479089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00479089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00479089 about?
NCT00479089 is a clinical study titled "Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer". Primary Objective: 1\. To compare the proportion of patients free from progression 9 months from the start of consolidation therapy with the combination of docetaxel and ZD1839 (Iressa) versus docetaxel alone. For the purposes of this protocol, "consolidation" therapy refers to treatment given at t...
What is the current status of trial NCT00479089?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2004-02. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00479089?
The interventions under investigation include: Docetaxel (DRUG), Dexamethasone (DRUG), ZD1839 (DRUG).
Who is sponsoring clinical trial NCT00479089?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00479089's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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