Gemcitabine With or Without WX-671 in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

Exclusion Criteria

• •* Any distant metastases
• •PATIENT CHARACTERISTICS:
• •* History of or current primary blood coagulation or bleeding disorders such as hemophilia
• •* Any unrelated illness, e.g., active infection, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect the patient's study participation
• •* Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug
• •* Significant cardiac insufficiency (NYHA classification III or IV), presence of unstable angina or myocardial infarction within the previous 6 months, use of ongoing maintenance therapy for life threatening arrhythmia or known pulmonary hypertension
• •* Any secondary malignancies within the last 5 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ
• •* Pregnancy (positive serum pregnancy test) or lactation
• •* Known hepatitis B/C or HIV infection
• •* Known hypersensitivity to any of the components in the anti-uPA serine protease inhibitor WX-671 capsules or gemcitabine hydrochloride infusion or other medical reasons for not being able to receive adequate pre-medication (for example, antihistamine or anti-inflammatory agents)
• •PRIOR CONCURRENT THERAPY:
• •Permitted:
• •* Embolization (i.e. for hematuria)
• •* Subjects can receive blood transfusions as medically appropriate during the study
• •* Subjects who require a blood transfusion during screening must have stable hemoglobin (≥9.0 g/dL \[5.6 mmol/L\]) without the need for further transfusions within 2 weeks before the first dose of anti-uPA serine protease inhibitor WX-671 to remain eligible
• •* Prophylactic use of growth factors to support neutrophils
• •Prohibited:
• •* Anticoagulant or thrombolytic therapy within four weeks prior to start of treatment (except low dose anticoagulant therapy with unfractionated heparin ≤ 15000 IU/d, low molecular weight heparin ≤ 5000 IE anti-Xa activity or acetyl salicylic acid ≤ 100 mg/d at the discretion of the investigator)
• •* Anticancer therapies such as biologic therapy and chemotherapy (other than study drugs)
• •* Radiation therapy (during the treatment phase of the protocol; increased bone pain not controlled by medication and requiring palliative therapy will be considered disease progression)
• •* Laser treatment
• •* Any other investigational agent
• •* Thalidomide
• •* Immunosuppressive therapies (inhaled or replacement dose corticosteroids are permitted).