Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation 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.