Conditions: Pancreatic Cancer Metastatic Pancreatic Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 109
Healthy volunteers: no

Brief summary:
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.

Detailed description:
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.

Arms:
arm 1: 400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib arm 2: placebo + 1000mg/m2 gemcitabine + 100mg erlotinib

Interventions: intervention 1: gemcitabine intervention 2: placebo intervention 3: Erlotinib intervention 4: apricoxib
Intervention descriptions: intervention 1: Gemcitabine: per package insert. intervention 2: placebo: 100 mg tablets, 400 mg/day intervention 3: Erlotinib - per package insert. intervention 4: apricoxib: 100mg tablets, given orally

Protocol document: