NCT01386398WithdrawnPhase 3
Progression Free Survival (PFS) Comparison Between Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat TM) in Combination With Bortezomib (Velcade TM) and SAHA Alone in Refractory or Recurrent Advanced CTCL. A Randomized Study.
European Organisation for Research and Treatment of Cancer - EORTC0 sitesStarted: July 1, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Primary Endpoint
- Progression-free survival
Study Overview
Brief Summary
RATIONALE: Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether vorinostat is more effective when given alone or when given together with bortezomib in treating patients with refractory or recurrent cutaneous T-cell lymphoma.
PURPOSE: This randomized phase III trial is studying how well vorinostat works when given alone compared with vorinostat given together with bortezomib in treating patients with refractory or recurrent stage IIB, stage III, or stage IV cutaneous T-cell lymphoma.
Detailed Description
OBJECTIVES:
Primary
- To determine if the combination of bortezomib plus vorinostat (SAHA) is more effective than vorinostat alone, in terms of prolonging progression-free survival, in patients with stage IIB-IV cutaneous T-cell lymphoma who have failed prior therapy.
Secondary
- To determine the overall survival of these patients.
- To determine the response rate in these patients.
- To determine the time to progression in these patients.
- To determine the duration of response in these patients.
- To determine the incidence of second cancers in these patients.
- To determine the acute and late toxicity of this regimen in these patients.
- To determine if translational research may provide insight into disease mechanism and identify biomarkers useful for prediction of treatment response. (Exploratory)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Progression-free survival
Secondary Outcomes
- Time to progression
- Duration of response
- Second cancers
- Acute and late toxicity
- Overall survival
- Response rate
Investigators
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