At a glance
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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).
In Brief
A Phase 1 clinical trial evaluating bevacizumab [Avastin], capecitabine [Xeloda], and 1 other intervention for Pancreatic Cancer. Completed, enrolled 32 participants across 2 sites.
Detailed Summary
This 2 part study will evaluate the safety and efficacy of a combination of Avastin, Tarceva and Xeloda (ATX) as second-line treatment in patients with locally advanced and/or metastatic pancreatic cancer. In the first part of the study, cohorts of patients will receive escalating doses of combination treatment to determine the maximum tolerated dose. The recommended dose will be used in the second part of the study to determine the efficacy of the ATX regime, in terms of its effect on disease progression. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
Escalating doses of 5/10mg/kg q2w
Escalating doses of 500/650/750/900mg/m2 bid
Escalating doses of 100/150mg daily