Study Stopped
CTEP Initiated Action
Carboplatin and Paclitaxel With or Without Vorinostat in Treating Patients With Advanced Non-Small Cell Lung Cancer
Phase II Randomized Study of Vorinostat or Placebo in Combination With Carboplatin and Paclitaxel for Patients With Advanced Non-small Cell Lung Cancer
9 other identifiers
interventional
23
1 country
13
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2010
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2010
CompletedFirst Submitted
Initial submission to the registry
August 5, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2013
CompletedResults Posted
Study results publicly available
August 18, 2015
CompletedNovember 12, 2024
October 1, 2024
2.4 years
August 5, 2011
June 5, 2015
October 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Estimated using the product-limit method of Kaplan and Meier. PFS defined as time from randomization to progression or death due to any cause. Progression defined as Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 1 year
Secondary Outcomes (2)
Dose Limiting Toxicity (DLT) (Phase I)
4 weeks from start of treatment, up to 1 year
Maximum Tolerated Dose (MTD) (Phase I)
4 weeks from start of treatment, up to 1 year
Study Arms (2)
Arm I (paclitaxel, carboplatin, vorinostat)
EXPERIMENTALPatients receive paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes on day 0. Patients also receive vorinostat PO once daily on days -2 to 2.
Arm II (paclitaxel, carboplatin, placebo)
ACTIVE COMPARATORPatients receive paclitaxel and carboplatin as in arm I. Patients also receive placebo PO once daily on days -2 to 2.
Interventions
Given IV
Correlative studies
Given IV
Given PO
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated early by NCI due to slow accrual.
Results Point of Contact
- Title
- DCC Project Administrator
- Organization
- California Cancer Consortium
Study Officials
- PRINCIPAL INVESTIGATOR
Chandra P Belani
City of Hope Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2011
First Posted
August 10, 2011
Study Start
November 8, 2010
Primary Completion
April 14, 2013
Study Completion
April 14, 2013
Last Updated
November 12, 2024
Results First Posted
August 18, 2015
Record last verified: 2024-10