Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients With Advanced Cancer

Date de début de l'étude : 1 juillet 2003

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.