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NCT00425750 · ClinicalTrials.gov registry record · Phase 2
Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00425750: Completed Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT00425750 is a Phase 2 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00425750, a Phase 2 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with docetaxel works in treating patients with recurrent or metastatic head and neck cancer.
Primary Outcome
Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Interventions
- OTHER laboratory biomarker analysis
- DRUG docetaxel
- OTHER pharmacological study
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2005-08 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00425750 record still lists
NCT00425750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00425750 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00425750 about?
NCT00425750 is a clinical study titled "Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer". RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, ei...
What is the current status of trial NCT00425750?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2005-08. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00425750?
The interventions under investigation include: laboratory biomarker analysis (OTHER), docetaxel (DRUG), pharmacological study (OTHER), bortezomib (DRUG).
Who is sponsoring clinical trial NCT00425750?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00425750's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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