Trial to Evaluate the Efficacy and Safety of Tarceva and Capecitabine in Advanced Pancreatic Cancer Patients
- Sponsor
- Grupo Gallego de Investigaciones Oncologicas
- Study ID
- NCT00873353
- Phase
- PHASE2
- Status
- Completed
Conditions
- Metastatic Adenocarcinoma of the Pancreas
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- capecitabine + erlotinib — DRUG6 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
Study Details
The purpose of this study is to determine efficacy of the treatment with erlotinib in combination with capecitabine in patients with advanced pancreatic cancer.
Key Dates
- First listed
- Apr 1, 2009
- Start date
- Mar 31, 2008
- Status verified
- Aug 2010
- Primary completion
- Aug 31, 2008
- Completion
- Aug 31, 2010
Study Design
- Enrollment
- 32 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Unique arm6 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
Primary Outcome Measure
Objective response rate following RECIST criteria [ Time Frame: within study period ]