drugset / Trial / NCT00091026

Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer

NCT00091026 ↗

Phase 2 Completed 143 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.

Timeline

Start
2004-07
Primary completion
2011-01
Completion
2011-01

Outcome

Missed primary endpoint

registry p = 0.22; Risk Difference (RD) 0 (95% CI -13 to 14) NCT00091026 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody — Intravenous
Subject Erlotinib Small molecule — Oral
Background Bevacizumab Monoclonal antibody — Intravenous
Background Gemcitabine Small molecule — Intravenous