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Capecitabine combinations in advanced gastric cancer
NCT00454636Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2007
- Primary completion
- Jul 2010
- Countries
- 1
- Sponsor
- Roche
- Modality
- DNA Intercalators/Alkylators, Irreversible Covalent Inhibitors, RNA-Targeting Small Molecules
- Drugs
- capecitabine
- Conditions
- gastric cancer (GC)
01
Overview
Phase 2, open-label trial of capecitabine in gastric cancer (GC) (4 arms), sponsored by Roche. Primary endpoint: Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) at 3.25 years. Started Mar 2007; status: completed.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Cisplatin / Capecitabine
Cisplatin 80 mg/m2 IV q3w + Capecitabine 1000 mg/m2 bid 2w on/1w off
Epirubicin / Cisplatin / Capecitabine
Epirubicin 50 mg/m2 IV q3w + Cisplatin 60 mg/m2 IV q3w + Capecitabine 625 mg/m2 bid continuous
Epirubicin / Oxaliplatin / Capecitabine
Epirubicin 50 mg/m2 IV q3w + Oxaliplatin 130 mg/m2 IV q3w + Capecitabine 625 mg/m2 bid continuous
Docetaxel / Cisplatin / Capecitabine
Docetaxel 60 mg/m2 IV q3w + Cisplatin 60 mg/m2 IV q3w + Capecitabine 825 mg/m2 bid 2w on/1w off
03
Who it enrols
Adult patients with advanced or metastatic gastric cancer, ECOG <= 2, no prior chemotherapy (except adjuvant/neoadjuvant >6 months prior), no CNS metastasis, no other malignancy within 5 years, and no clinically significant cardiac disease.
04
Endpoints
Primary
Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
Secondary
Overall Response Rate
Progression-Free Survival
Overall Survival
Duration of Response
Time to Response
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