Carboplatin and Paclitaxel With or Without Vorinostat in Treating Patients With Advanced Non-Smal… (NCT01413750) | Clinical Trial Compass
TerminatedPhase 2
Carboplatin and Paclitaxel With or Without Vorinostat in Treating Patients With Advanced Non-Small Cell Lung Cancer
Stopped: CTEP Initiated Action
United States23 participantsStarted 2010-11-08
Plain-language summary
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 is more effective with or without vorinostat in treating non-small cell lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically confirmed non-small cell lung cancer
* No prior chemotherapy for advanced or metastatic disease
* ECOG performance status 0 or 1
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
* Life expectancy of greater than 12 weeks
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SGPT) =\< 2.5 x institutional upper limit of normal
* Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy in a metastatic setting
* Patients may not be receiving any other investigational agents
* Patients with untreated brain metastases should be excluded from this clinical trial; however, patients who have stable brain disease (should be off corticosteroids) at least 3 weeks after completion of appropriate therapy are eligible
* Patients who have received any prior HDAC inhibitor (except valproic acid for seizure control provided that the valproic acid has been stopped at least 30 days …
What they're measuring
1
Progression-free Survival (PFS)
Timeframe: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 1 year