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NCT00481078 · ClinicalTrials.gov registry record · Phase 2
Vorinostat, Carboplatin, and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT00481078: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00481078 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 94 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00481078, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study Summary
This randomized phase II trial is studying carboplatin, paclitaxel, and vorinostat to see how well they work compared with carboplatin, paclitaxel, and a placebo in treating patients with stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carboplatin and paclitaxel together with vorinostat is more effective than giving carboplatin and paclitaxel together with a placebo in treating non-small cell lung cancer
Primary Outcome
Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data). Patients with confirmed CR or PR according to the RECIST criteria were considered to have responded to treatment.
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- DRUG carboplatin
- DRUG vorinostat
- DRUG paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00481078 record still lists
NCT00481078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00481078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00481078 about?
NCT00481078 is a clinical study titled "Vorinostat, Carboplatin, and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer". This randomized phase II trial is studying carboplatin, paclitaxel, and vorinostat to see how well they work compared with carboplatin, paclitaxel, and a placebo in treating patients with stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel...
What is the current status of trial NCT00481078?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2007-05. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00481078?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), carboplatin (DRUG), vorinostat (DRUG), paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00481078?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00481078's enrollment target sits among peer trials
94 764th of 2000 higher than 1,235 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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