Status:
TERMINATED
Carboplatin and Paclitaxel With or Without Vorinostat in Treating Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVES: I. To compare progression-free survival associated with the combination of carboplatin, paclitaxel and vorinostat versus carboplatin, paclitaxel and placebo for patients with prev...
Eligibility Criteria
Inclusion
- 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
- 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 before beginning therapy on this protocol) are excluded from this study
- Peripheral neuropathy of severity greater than grade 1
- Known history of allergic reactions to paclitaxel
- Prior therapy with paclitaxel
- Inability to take oral medications on a continuous basis; patients unable to swallow the vorinostat capsules whole are ineligible (the capsules cannot be crushed or broken)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with vorinostat; women of childbearing potential must use an appropriate double barrier method of birth control (such as female use of a diaphragm, intrauterine device \[IUD\], sponge and spermicide, in addition to the male use of a condom) or a prescribed birth control implant or practice abstinence; both double barrier contraception and implants must be used for at least one week prior to the start of the research study and continue for at least two weeks following the last study visit; please note that birth control pills should not be used while on this study as they may have a negative interaction with the experimental drug in this study
- HIV-positive patients receiving combination antiretroviral therapy are ineligible
Key Trial Info
Start Date :
November 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01413750
Start Date
November 8 2010
End Date
April 14 2013
Last Update
November 12 2024
Active Locations (13)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612