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Weekly Oxaliplatin and Irinotecan in Esophageal Cancer
NCT00256269Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2005
- Primary completion
- Feb 2007
- Countries
- 1
- Sponsor
- University of California, Irvine
- Modality
- Nanoparticles, Monoclonal Antibodies, DNA Intercalators/Alkylators
- Conditions
- esophageal carcinomagastroesophageal junction adenocarcinoma
01
Overview
Phase 2, open-label, single-arm trial of oxaliplatin and irinotecan hydrochloride liposome injection (II) + temozolomide + bevacizumab in esophageal carcinoma and gastroesophageal junction adenocarcinoma, sponsored by University of California, Irvine. Primary endpoint: Overall Response Rate at 5 years. Started Jun 2005; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Oxaliplatin plus Irinotecan
Oxaliplatin 40 mg/m2 IV and Irinotecan 60 mg/m2 IV every 21 days
03
Who it enrols
Patients with histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or GE junction, with locally advanced or metastatic disease, adequate organ function, and no prior chemotherapy for metastatic disease.
04
Endpoints
Primary
Overall Response Rate
Secondary
Number of participants with treatment-related adverse events
Progression Free Survival
Time to Death
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