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).
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer
Both
Pancreatic Cancer
Trial Information
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).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Austria:BASG
Study ID:
ML20784
NCT ID:
NCT00925769
Start Date:
December 2008
Completion Date:
June 2013
Related Keywords:
- Pancreatic Cancer
- Pancreatic Neoplasms
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