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GECA: Gemcitabine-Erlotinib vs Gemcitabine-Erlotinib-Capecitabine in Pancreatic Cancer
NCT01303029Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2011
- Primary completion
- Jun 2015
- Countries
- 1
- Sponsor
- Spanish Cooperative Group for Digestive Tumour Therapy
- Modality
- DNA Intercalators/Alkylators, Irreversible Covalent Inhibitors, RNA-Targeting Small Molecules
- Drugs
- capecitabine
- Conditions
- pancreatic cancer (PC)
01
Overview
Phase 2, randomised, open-label trial of capecitabine in pancreatic cancer (PC) (2 arms), sponsored by Spanish Cooperative Group for Digestive Tumour Therapy. Primary endpoint: Progression Free Survival at 4 years. Started Feb 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Gemcitabine + Erlotinib
Gemcitabine 1000mg/m2 (d1,8,15) + Erlotinib 100mg daily
Gemcitabine + Erlotinib + Capecitabine
Gemcitabine 1000mg/m2 (d1,8,15) + Erlotinib 100mg daily + Capecitabine 1660mg/m2 (d1-21)
03
Who it enrols
Patients with metastatic pancreatic adenocarcinoma, ECOG 0-2, adequate organ function, and no prior systemic therapy for metastatic disease.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Survival
Response Rate
Duration of Response
Number of Participants with Adverse Events
Percentage of rash in patients treated with erlotinib and correlation with PFS/OS
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