Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)

Exclusion Criteria

• •current symptomatic central nervous system (CNS) involvement
• •prior or co-existent malignancies
• •significant non-malignant disease
• •acute or chronic gastrointestinal (GI) bleeding in last two years
• •inflammatory bowel disease
• •abnormal bleeding tendency
• •patients at risk of bleeding due to open wounds or planned surgery
• •clinically significant hemoptysis within the past 4 weeks
• •bilirubin \> upper limit of normal (ULN)
• •ALT and AST \> 2.5 times ULN, or \> 1.5 times ULN if alkaline phosphatase \> 2.5 times ULN
• •alkaline phosphatase \> 5 times ULN, unless patient has bone metastases
• •myocardial infarction, stroke or congestive heart failure within last 3 months
• •prior treatment with docetaxel
• •concomitant treatment with aspirin (\>100 mg/day), NSAIDs (except selective COX-2 inhibitors, warfarin (\>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4 inhibitors
• •women who are pregnant or breast-feeding
• •women of child-bearing potential not using adequate contraception
• •history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
• •history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease
• •allergy to polysorbate 80 (component of Taxotere®)
• •uncontrolled or serious infection in last 4 weeks