The purpose of this study is to determine efficacy of the treatment with erlotinib in combination with capecitabine in patients with advanced pancreatic cancer.
This efficacy will be determined by objective response rate following RECIST criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
6 cycles (3 weeks each one) of : * capecitabine 1000mg/m2, bid, oral. Days: 1-14 every three weeks * erlotinib (Tarceva®) 150mg/day, oral. Days: every days
Complejo Hospitalario Universitario de La Coruña
A Coruña, La Coruña, Spain
Centro Oncológico de Galicia
A Coruña, La Coruña, Spain
Hospital Arquitecto Marcide
Ferrol, La Coruña, Spain
Complejo Hospitalario Xeral Calde
Lugo, Lugo, Spain
Objective response rate following RECIST criteria
Time frame: within study period
Overall survival
Time frame: within study period
6 months survival rate
Time frame: within first 6 months after study inclusion
Progression Free Survival (PFS)
Time frame: Time from study inclusion to disease progression
Time to treatment failure (TTF)
Time frame: Time from study inclusion to treatment failure
To determine the index of clinical benefit
Time frame: at the end of the study
To determine the safety and tolerability of erlotinib and capecitabine when administered together
Time frame: Within study period
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Complejo Hospitalario de Orense
Ourense, Orense, Spain
Hospital do Meixoeiro
Vigo, Vigo, Spain
Complejo Hospitalario Xeral Cies
Vigo, Vigo, Spain
Hospital POVISA
Vigo, Vigo, Spain