Conditions: Metastatic Pancreatic Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 861
Healthy volunteers: no

Brief summary:
Phase III Metastatic Pancreatic Cancer

Detailed description:
A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the pancreas.

Arms:
arm 1: ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest. arm 2: Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).

Interventions: intervention 1: Albumin-bound paclitaxel (ABI-007) intervention 2: Gemcitabine
Intervention descriptions: intervention 1: ABI-007 125 mg/m\^2 administered by intravenous infusion intervention 2: Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

Protocol document: