CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
vorinostat +1 moredrug
Likely dose
Vorinostat (SAHA) administered orally; specific dose not stated in interventions or armsAI-extracted
Key inclusion· 6
  • Histologically or cytologically confirmed NSCLC, Stage IV with distant metastases, Stage IIIB with malignant pleural effusion, or recurrent disease
  • Measurable disease: ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • No more than 1 prior cytotoxic chemotherapy regimen for Stage IIIB/IV or recurrent disease
  • Life expectancy >3 months
Key exclusion· 5
  • Chemotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C) prior to study entry
  • Radiotherapy within 3 weeks prior to study entry
  • Any other active malignancy in the past 5 years except non-melanoma skin cancers
  • Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness limiting compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00138203
NCT00138203Phase 2Completed

A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Non-small Cell Lung Cancer

National Cancer Institute (NCI)·interventional·Posted Aug 30, 2005·Updated Jan 30, 2018

In Brief

A Phase 2 clinical trial evaluating vorinostat and laboratory biomarker analysis for Recurrent Non-small Cell Lung Cancer and 2 related conditions. Completed, enrolled 16 participants across 5 sites.

Detailed Summary

This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 30, 2005
Enrollment StartJun 1, 2005
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.8 years ago

Interventions

vorinostatdrug

Given PO

laboratory biomarker analysisother

Correlative studies