Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract

Exclusion Criteria

• •1. Patients who have received prior therapy with any taxane.
• •2. Patients who have a past or current history of cancer other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
• •3. Patients with symptomatic brain metastasis (es).
• •4. Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
• •5. Patients with active infections currently receiving anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
• •6. Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
• •7. Patients with unstable or serious concurrent medical conditions are excluded.
• •8. Patients with a known hypersensitivity to Cremophor®.
• •9. Patients with one or more of the following as the only manifestations of disease are ineligible: bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, carcinomatous lymphangitis, central nervous system (CNS) metastases, lesions in a previously irradiated area that have not shown definite progression, or disease only inferred from laboratory tests or markers.
• •10. Patients with a history of Gilbert's Syndrome.
• •11. Patients must not receive any concurrent chemotherapy, radiotherapy, non-FDA approved nutritional supplements or herbal preparations or immunotherapy while on study.
• •12. Known HIV disease or infection.
• •13. Patients receiving ketoconazole, erythromycin, verapamil, diazepam, quinidine or diltiazem.
• •14. Patients must not have had any surgical procedure requiring hospitalization and administration of general anesthesia within the past 28 days.
• •15. Patients must not have received prior systemic chemotherapy for advanced disease. Prior adjuvant systematic chemotherapy (non-taxane containing) is allowed.