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Carboplatin Plus Celecoxib in Recurrent Ovarian Cancer
NCT01124435Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2003
- Primary completion
- Sep 2007
- Countries
- 1
- Sponsor
- Università Cattolica del Sacro Cuore
- Modality
- Small Molecules
- Conditions
- ovarian cancer
01
Overview
Phase 2, open-label, single-arm trial of celecoxib oral solution in ovarian cancer, sponsored by Università Cattolica del Sacro Cuore. Primary endpoint: Overall Response Rate at 48 months. Started Oct 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Carboplatin plus Celecoxib
Celecoxib 200 mg tablets by mouth twice daily, day 1 to 28, associated to intravenous carboplatin AUC 5 over 30 to 60 minutes, every 28 days.
03
Who it enrols
Adults with recurrent epithelial ovarian, fallopian tube, or peritoneal serous carcinomas, measurable disease, prior platinum therapy, and at least one prior line for recurrent disease. Excludes patients with significant cardiovascular, GI, or thromboembolic comorbidities, or prior COX2 inhibitor use.
04
Endpoints
Primary
Overall Response Rate
Secondary
Toxicity Assessment
Progression-Free Survival
Overall Survival
Duration of Response
Quality of Life
Modulation of angiogenesis-related molecules
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