Clinical Trials >> Pancreas >> TeloVac >> Treatment

Treatment/Intervention

This study is designed as a prospective, phase III, controlled, open label, multicentre, randomised clinical trial comparing combination Gemcitabine and Capecitabine therapy with concurrent and sequential immunotherapy using the telomerase vaccinne GV 1001 in locally advanced and metastatic pancreatic cancer. Patients will be treated until disease progression and will be subject to follow-up until death. Patients will be randomised equally between the three arms:

• Gemcitabine & Capecitabine
• Gemcitabine and Capecitabine then sequential GV1001 followed by further Gemcitabine and capecitabine for patients where no progressive disease (PD) was demonstrated upon the week 8 CT Concurrent administration of Gemcitabine and Capecitabine and GV1001.
• Concurrent administration of Gemcitabine and Capecitabine and GV1001

Patients will be stratified by: Stage of disease (locally advanced vs. metastatic) and Performance status (0 versus 1 versus 2)

Target recruitment is 1110 patients (370 within each arm).

The Capecitabine will be fully funded by Roche Pharmaceuticals and will be distributed free of charge. See BJC paper-for phase I/II full paper {ref: CTN 1-2000 BJC paper.pdf}.