NCT00798720

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2008

Typical duration for phase_2

Status
completed

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

First Submitted

Initial submission to the registry

November 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

November 21, 2016

Completed
Last Updated

December 13, 2019

Status Verified

September 1, 2016

Enrollment Period

3.8 years

First QC Date

November 25, 2008

Results QC Date

April 28, 2016

Last Update Submit

December 11, 2019

Conditions

Carcinoma, Non Small Cell Lung

Keywords

non small cell lung cancerHDACproteasome inhibitor

Outcome Measures

Primary Outcomes (1)

  • Three-month Progression-free Survival

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions."

    Three-months post-treatment

Secondary Outcomes (3)

  • Response Rate

    Until disease progression, up to 2 years

  • Median Overall Survival

    5 years

  • Toxicity

    30 days post-treatment

Study Arms (1)

Vorinostat + Bortezomib

EXPERIMENTAL

Vorinostat 400 mg + Bortezomib 1.3 mg/m2

Drug: vorinostatDrug: bortezomib

Interventions

vorinostatDRUG

400 mg by mouth once daily for days 1-14 of each 21 day cycle

Also known as: SAHA, Zolinza
Vorinostat + Bortezomib
bortezomibDRUG

1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

Also known as: PS341, Velcade
Vorinostat + Bortezomib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

VorinostatBortezomib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic AcidsBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Abigail Mapes, Thoracic Oncology Research Program Manager
Organization
University of Wisconsin
acmapes@medicine.wisc.edu
(608) 262-8158

Study Officials

  • Tien Hoang, M.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 26, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 13, 2019

Results First Posted

November 21, 2016

Record last verified: 2016-09