drugset / Trial / NCT00425360

Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT00425360

Phase 3 Completed 1110 enrolled Royal Liverpool University Hospital
RandomizedOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving more than one drug (combination chemotherapy) together with vaccine therapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective with or without vaccine therapy in treating pancreatic cancer. PURPOSE: This randomized phase III trial is studying gemcitabine, capecitabine, and vaccine therapy to see how well they work compared with gemcitabine and capecitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.

Timeline

Start
2006-09
Primary completion
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject TERTOMOTIDE Vaccine Other
Background Capecitabine Small molecule Oral
Background Gemcitabine Small molecule Intravenous
Background sargramostim Protein / enzyme biologic Other