Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer

• Patients must have advanced histologically diagnosed non-hematological malignancy for which there is no curative therapy and for which treatment with single agent paclitaxel is appropriate in the opinion of the investigator.
• Patients must have a life expectancy of 12 weeks or more.
• Patients must have an ECOG Performance Status of 0-2.

• Patients must have recovered from acute toxicities of prior treatment. Specifically: *4 or more weeks must have elapsed since receiving any investigational agent. *3 or more weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (6 weeks or more for mitomycin or nitrosureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted. *2 or more weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.

  • Patients must be in adequate condition as evidenced by the following clinical laboratory values: *Absolute neutrophil count (ANC) ≥1,500/mm³, *Platelet count ≥100,000/mm³, *Hemoglobin ≥9.0 g/dL, *Albumin ≥3.0 g/dl, *Serum creatinine ≥2.0 mg/dL, *Total bilirubin 1.5 x the institutional upper limit of normal (ULN) or greater. *Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN. In the case of known liver metastasis, ALT and AST ≤5 x ULN. *Alkaline phosphatase (ALP) ≤2.5 x ULN. No ULN applies to alkaline phosphatase in the case of known bone metastasis.
  • Patients (male and female) must be willing to practice an effective method of birth control during the study.
  • Patients must be available for and able to comply with the study-specific blood sampling requirements for pharmacokinetic evaluations.
  • Patients or legal representative must understand the investigational nature of this study and sign an Institutional Review Board (IRB) approved written informed consent form prior to treatment.

Exclusion Criteria:

• Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
• Any active infection requiring parenteral or oral antibiotic treatment; any use of trimethoprim, including use for antimicrobial prophylaxis.
• Known infection with human immunodeficiency virus (HIV) or hepatitis virus.
• Active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or arrhythmias currently requiring medication.
• Known or suspected active central nervous system metastasis. (Patients stable 8 weeks after completion of treatment for central nervous system metastasis are eligible.)
• Impending or symptomatic spinal cord compression or carcinomatous meningitis.
• Having pre-existing clinically significant neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) greater than or equal to Grade 2 neuromotor or Grade 2 neurosensory) except for abnormalities due to cancer.
• Having known hypersensitivity to paclitaxel or liposomes.
• Receiving any agent that could interfere with LEP-ETU metabolism, including CYP3A4 inducers and inhibitors within 3 weeks prior to, or while receiving, study drug (Please refer to http://medicine.iupui.edu/flockhart/ for a list of such agents).
• Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
• Female patients who are pregnant or breast feeding.
• Unwilling or unable to follow protocol requirements.
• Any condition which, in the Investigator's opinion, deems the patient an unsuitable candidate to receive study drug.