An Open Label Study to Evaluate the Safety and Effect on Disease Progression of Triple Combination Treatment With Erlotinib (Tarceva), Bevacizumab (Avastin), and Capecitabine (Xeloda) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer (REBECA-Trial).
- adult patients, >=18 years of age;
- pancreatic cancer with locally advanced and/or metastatic disease (stage IV);
- chemonaive for metastatic or locally advanced disease;
- ECOG performance status of 0-2.
- local (stage IA to IIB)and locally advanced (stage III) pancreatic cancer;
- previous exposure to Avastin, Tarceva or Xeloda;
- other primary tumor within the last 5 years prior to enrollment, except for
adequately treated cancer in situ of cervix, or basal cell skin cancer;
- current or recent chronic use of aspirin (>325 mg/day) or full therapeutic dose of
anticoagulants or thrombolytic agents.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse events, laboratory parameters (Part 1)
Outcome Time Frame:
on days 1-8 of 1st 2-week cycle and on days 1 and 8 of every following cycle
- Pancreatic Cancer
- Pancreatic Neoplasms