Clinical trial · Interventional
Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer
Phase II Study of Vorinostat (SAHA, Zolinza) and Bortezomib (PS341, Velcade) as Third-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
NCT00798720CI-TRIAL-00042239completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non Small Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vorinostat + Bortezomib
- description
- Vorinostat 400 mg + Bortezomib 1.3 mg/m2
- interventionNames
- Drug: vorinostat
- Drug: bortezomib
Primary outcomes (1)
- measure
- Three-month Progression-free Survival
- timeFrame
- Three-months post-treatment
- description
- 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 (3)
- measure
- Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.