Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer

Inclusion Criteria:

* Patients must have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments, and no life-prolonging therapy or therapy with a greater potential for patient benefit is available.
* Patients must have an ECOG Performance Status of 0-2.
* Patients must have recovered from acute toxicities of prior treatment:

  * ≥ 4 weeks must have elapsed since receiving any investigational agent.
  * ≥ 3 weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥ 6 weeks for mitomycin or nitrosureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted.
  * \> 6 months must have elapsed since receiving a high-dose chemotherapy regime with stem cell support.
  * ≥ 2 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).
  * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤2.5 x ULN.
* Patients (male and female) must be willing to practice an effective method of birth control during the study.
* Patients or legal representative must understand the investigational nature of this study and sign and 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.
* 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 (NCI CTCAE Grade ≥ 2 neuromotor or Grade 2 neurosensory) except for abnormalities due to cancer.
* Having received prior treatment with LEP-ETU.
* 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).
* Currently receiving any other standard or investigational treatment for cancer or any other investigational agent for any indication.
* 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.