PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial
- Assess 6-months progression-free survival of patients with stage III or IV
adenocarcinoma of the pancreas treated with cisplatin, capecitabine, gemcitabine
hydrochloride (PXG) and epirubicin hydrochloride vs PXG and docetaxel.
- Evaluate the activity and toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I (PEXG): Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on
days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to
6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (PGDX): Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin
hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every
28 days for up to 6 courses in the absence of disease progression or unacceptable
Patients may then undergo surgery if the tumor becomes resectable.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6-months
every 2 months during therapy; every 3 months thereafter
Michele Reni, MD
Istituto Scientifico H. San Raffaele
Italy: Ministry of Health