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Bortezomib + Cisplatin in Malignant Mesothelioma
NCT00458913Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2007
- Primary completion
- Apr 2010
- Countries
- 1
- Sponsor
- European Organisation for Research and Treatment of Cancer
- Modality
- Small Molecules, Modified Peptides
- Drugs
- bortezomib
- Conditions
- malignant mesothelioma
01
Overview
Phase 2, open-label, single-arm trial of bortezomib in malignant mesothelioma, sponsored by European Organisation for Research and Treatment of Cancer. Primary endpoint: Progression-free survival rate at 18 weeks. Started Feb 2007; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Bortezomib + Cisplatin
Patients receive cisplatin IV over 1 hour on day 1 and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 3 weeks.
03
Who it enrols
Patients with histologically confirmed pleural malignant mesothelioma, measurable disease, WHO PS 0-1, and adequate organ function. No prior systemic chemotherapy for mesothelioma.
04
Endpoints
Primary
Progression-free survival rate at 18 weeks
Secondary
Overall objective response rate
Symptomatic response rate
Safety as measured by NCI CTCAE v3.0 and FACT/GOG-Ntx
Duration of PFS
Overall survival
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