Oral Treatment With BIBF 1120 Together With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer

Inclusion criteria

• Patients with histologically-proven metastatic prostate adenocarcinoma
• Progression after hormonal therapy
• Progressive disease as follows:

• Increase of PSA > 5 ng/ml on two occasions despite castrate levels of testosterone before screening
• AND/OR Progressive measurable disease (RECIST criteria)
• AND/OR Progressive bone metastases (presence of new lesion(s) on a bone scan)
• Life expectancy of at least three months
• ECOG performance status ≤ 2
• Patient written informed consent obtained prior to any trial procedures and that is consistent with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) guidelines.

Exclusion criteria

• Prior treatment for hormone refractory prostate cancer (HRPC) including chemotherapy, biologic response modifier therapy, or any investigational drug
• Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
• Major injuries and surgeries within the past 4 weeks. Planned surgical procedures during the trial
• Brain metastases
• Radiotherapy superior to 30% of the medullar volume
• Other malignancy diagnosed within the past 5 years (other than non-melanomatous skin cancer)
• Gastrointestinal abnormalities that would interfere with intake or absorption of the study drug, such as a requirement for intravenous alimentation, prior surgical procedures affecting absorption, treatment for peptic ulcer disease within the last 6 months, active gastrointestinal bleeding unrelated to cancer (as evidenced by either hematemesis, or melena in the past 3 months and without endoscopic documented resolution), or malabsorption syndromes
• Previous history of stroke, angor pectoris, ischemic cardiomyopathy, cerebral ischemia, arteritis in the past 6 months
• Recent history of hemorrhagic or evolutive thrombotic event (including transient ischemic attacks) in the past 6 months
• Patients who require full-dose anticoagulation or heparinization
• Absolute neutrophil count (ANC) < 1,500/μl, platelet count < 100,000/μl, or hemoglobin < 8 mg/dL
• Total bilirubin > upper limit of normal (ULN); alanine amino transferase (ALT) and/or aspartate amino transferase (AST) >1.5 X ULN
• Serum creatinine > 1.5 mg/dL (> 132 μ mole/L, SI Unit equivalent)
• Known or suspected active alcohol or drug abuse
• Patients unable to comply with the protocol