Phase 2 Completed N=18 Treatment

Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer

Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov NCT00798720 ↗

Enrolled (actual)

Serious AEs

44.4%

Results posted

Nov 2016

Primary outcomePrimary: Three-month Progression-free Survival — 11.1 percentage of participants

Summary

The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy) and tolerability of this regimen.

Outcome Measures

Outcome	Result	p-value
PRIMARY Three-month Progression-free Survival	11.1	—
SECONDARY Response Rate	0; 5; 13	—
SECONDARY Median Overall Survival	4.7	—
SECONDARY Toxicity	7; 1; 3; 4; 1; 2	—

Eligibility Criteria

Inclusion Criteria

Pathologically/histologically confirmed NSCLC
Advance NSCLC (stage IIIB w/ effusion, stage IV, or recurrent disease)
Measurable disease
Two prior systemic anti-cancer (cytotoxic or biologic) regimens for advanced/metastatic disease, including one (1) platinum-based chemotherapy
Prior treatment allowed if side effects have resolved and 3 weeks has passed since last dose of treatment (1 week for palliative radiation therapy)
ECOG performance status 0, 1, or 2
Patients with brain metastases are allowed, if clinically stable after treatment
Normal liver, kidney, and marrow function
18 years of age or older
Negative pregnancy test for women of child-bearing potential.
Life expectancy 3 months or more
No concurrent use of other antitumor agents

Exclusion Criteria

Prior therapy with vorinostat, HDAC inhibitors, or bortezomib
Pre-existing neuropathy grade >/= 2
Myocardial infarction within 6 months prior to enrollment or have NY Heart Association Class III or Class IV heart failure
Have taken valproic acid </= 4 weeks prior to enrollment
Previous or current malignancies of other histologies within the past 5 years, except cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
Hypersensitivity to bortezomib, boron, or mannitol
Serious medical or psychiatric illness likely to interfere with participation in the clinical study
Pregnant women
HIV positive patients
Hepatitis infection (HCV or HBV) patients

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00798720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.