Status:
COMPLETED
Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer
Lead Sponsor:
INSYS Therapeutics Inc
Conditions:
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 wit...
Detailed Description
LEP-ETU is a new formulation of the anti-cancer agent paclitaxel for injection or Taxol (paclitaxel and Cremophor EL). Paclitaxel is a drug currently used for treating a broad range of cancers. Paclit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00080418
Start Date
July 1 2003
End Date
June 1 2010
Last Update
July 4 2011
Active Locations (3)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
2
Cancer Institute of New Jersey - University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States, 08903
3
Fox Chase Temple Cancer Center - Temple University
Philadelphia, Pennsylvania, United States, 19140