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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion to patients with advanced cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: INSYS Therapeutics Inc
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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.