Conditions: Pancreatic Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 33
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.

Detailed description:

Arms:
arm 1: Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily arm 2: Gemcitabine 850 mg/m2 + vatalanib 1250 mg arm 3: Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter arm 4: Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

Interventions: intervention 1: Vatalanib intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours intervention 2: 850 mg/m2

Protocol document: