Conditions: Metastatic Pancreatic Cancer
Keywords: Pancreatic Cancer
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 25
Healthy volunteers: no

Brief summary:
Phase I study of lapatinib and gemcitabine for patients with metastatic pancreaticobiliary cancer.

Detailed description:
To evaluate the safety/tolerability and potential antitumor activity of lapatinib, at dose ranges of 1000 to 1500 mg/d, in combination with gemcitabine and gemcitabine/oxaliplatin (GEMOX) in patients with advanced pancreaticobiliary cancer.

Arms:
arm 1: Gemcitabine 1000mg/m2 with lapatinib 1000mg/d weekly x 3 weeks arm 2: Gemcitabine 1000mg/m2 with lapatinib 1500mg/d weekly X 3 weeks arm 3: gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1000 mg/d arm 4: gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1500 mg/d

Interventions: intervention 1: Gemcitabine 1000mg/m2 30 minutes intervention 2: Lapatinib 1000mg/d intervention 3: Lapatinib 1500mg/d intervention 4: Gemcitabine 1000mg/m2 100minutes intervention 5: Oxaliplatin 100mg/m2
Intervention descriptions: intervention 1: 1000mg/m2 30 minutes intervention 2: 1000mg/d intervention 3: 1500mg/d intervention 4: 1000mg/m2 100minutes intervention 5: 100mg/m2

Protocol document: