Trial · NCT00481078
Vorinostat, Carboplatin, and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
NCT00481078, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vorinostat, Carboplatin, and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. Trials, record NCT00481078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00481078
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vorinostat, Carboplatin, and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
- NCT number
- NCT00481078
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 94 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Interventions
- vorinostat, paclitaxel, carboplatin, placebo, laboratory biomarker analysis
- First posted
- 2007-06-01
- Last updated
- 2014-10-30
- Results first posted
- 2014-10-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | Assessed every two cycles | 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. |
| Secondary | Progression-free Survival | Up to 1 year | Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test. |
| Secondary | Overall Survival | Up to 1 year | Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | Assessed every two cycles | percentage of responding patients | NUMBER | |
| SECONDARY | Progression-free Survival | Up to 1 year | Months | MEDIAN | |
| SECONDARY | Overall Survival | Up to 1 year | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 34 | 95% Confidence Interval 22 to 47 | percentage of responding patients | |
| Response Rate | Arm II (Placebo, Paclitaxel, Carboplatin) | 12.5 | 95% Confidence Interval 4 to 29 | percentage of responding patients | |
| Progression-free Survival | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 6 | 95% Confidence Interval 4.3 to 6.9 | Months | |
| Progression-free Survival | Arm II (Placebo, Paclitaxel, Carboplatin) | 4.1 | 95% Confidence Interval 1.9 to 5.5 | Months | |
| Overall Survival | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 13 | 95% Confidence Interval 9.7 to NA | Months | |
| Overall Survival | Arm II (Placebo, Paclitaxel, Carboplatin) | 9.7 | 95% Confidence Interval 6 to 13 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 62 | |
| Overall Study | STARTED | Arm II (Placebo, Paclitaxel, Carboplatin) | 32 | |
| Overall Study | COMPLETED | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 20 | |
| Overall Study | COMPLETED | Arm II (Placebo, Paclitaxel, Carboplatin) | 12 | |
| Overall Study | NOT COMPLETED | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 42 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo, Paclitaxel, Carboplatin) | 20 |
Source ClinicalTrials.gov
Adverse events448
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 1 | 61 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (Placebo, Paclitaxel, Carboplatin) | 0 | 32 | 0 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 43 | 61 | 126 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II (Placebo, Paclitaxel, Carboplatin) | 21 | 32 | 71 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 1 | 61 | 1 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II (Placebo, Paclitaxel, Carboplatin) | 0 | 32 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 1 | 61 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Arm II (Placebo, Paclitaxel, Carboplatin) | 1 | 32 | 1 |
| other | Cardiac disorder | Cardiac disorders | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 0 | 61 | 0 |
| other | Cardiac disorder | Cardiac disorders | Arm II (Placebo, Paclitaxel, Carboplatin) | 1 | 32 | 1 |
1 to 10 of 448Source ClinicalTrials.gov
See all 448 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Vorinostat, Paclitaxel, Carboplatin) | ||
| Total, all-cause mortality | Arm II (Placebo, Paclitaxel, Carboplatin) | ||
| Total, other adverse events | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 61 | 61 |
| Total, other adverse events | Arm II (Placebo, Paclitaxel, Carboplatin) | 32 | 32 |
| Total, serious adverse events | Arm I (Vorinostat, Paclitaxel, Carboplatin) | 29 | 61 |
| Total, serious adverse events | Arm II (Placebo, Paclitaxel, Carboplatin) | 10 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Vorinostat, Paclitaxel, Carboplatin) vs Arm II (Placebo, Paclitaxel, Carboplatin): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00481078
GET https://conductscience.org/api/trials/v1/NCT00481078/events?page=2