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

Inclusion Criteria:

* 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.