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NCT Number: NCT00798720

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

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.

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Key information

Conditions

Carcinoma, Non Small Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Current treatment for non-small cell lung cancer (NSCLC) remains inadequate. Vorinostat is a novel agent that inhibits the enzymatic activity of histone deacetylases (HDACs). Bortezomib is a small molecule proteasome inhibitor. Preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of NSCLC

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vorinostat

Drug

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

Other names: SAHA, Zolinza

bortezomib

Drug

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

Other names: PS341, Velcade

Primary outcomes

  1. Three-month Progression-free Survival

    Time frame: Three-months post-treatment

    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."

Secondary outcomes

  1. Response Rate

    Time frame: Until disease progression, up to 2 years

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI, CT, or chest x-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.

  2. Median Overall Survival

    Time frame: 5 years

  3. Toxicity

    Time frame: 30 days post-treatment

    Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

Phase II Study of Vorinostat (SAHA, Zolinza) and Bortezomib (PS341, Velcade) as Third-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 26, 2008
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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