PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma

This is an open-label, phase II multi-center therapeutic trial investigating the efficacy and tolerability of PTK787/ZK222584 in patients with metastatic or advanced pancreatic cancer who failed first line gemcitabine-based therapy. The primary objective of this study is to evaluate the 6-month survival rate, time to progression, and tolerability of the regimen in pancreatic cancer patients treated with PTK787/ZK222584 as second-line therapy.

Inclusion criteria

• Age > 18
• Zubrod performance status of 0 - 2
• Histological or cytological diagnosis of pancreatic adenocarcinoma
• Measurable or evaluable disease determined as per RECIST criteria
• Life expectancy > 12 weeks
• Written informed consent
• Patients must have failed or progressed on prior gemcitabine-based therapy for advanced or metastatic disease.

Exclusion criteria

• Islet cell or neuroendocrine carcinomas of the pancreas.
• History or presence of central nervous system disease.
• Patients with a history of another primary malignancy < 5 years
• Prior chemo therapy < 21 days prior to registration.
• Prior biologic or immunotherapy < 14 days prior to registration
• Prior full field radiotherapy < 28 days or limited field radiotherapy < 14 days prior to registration.
• Major surgery < 28 days prior to registration.
• Patients who have received investigational drugs < 28 days prior to registration.
• Prior therapy with anti-VEGF agents.
• Pleural effusion or ascites that causes respiratory compromise.
• Female patients who are pregnant or breast feeding.