Status:
COMPLETED
Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer
Lead Sponsor:
INSYS Therapeutics Inc
Conditions:
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
In this study, Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is being compared to Taxol® to examine whether the paclitaxel in these 2 formulations undergoes similar processing by the body. Safet...
Detailed Description
This Phase 1B, open-label, two-period crossover bioequivalence study is designed to compare the pharmacokinetics (PK) of LEP-ETU and Taxol in patients with advanced cancer. Patients are randomized to ...
Eligibility Criteria
Inclusion
- Patients must have advanced histologically diagnosed non-hematological malignancy for which there is no curative therapy and for which treatment with single agent paclitaxel is appropriate in the opinion of the investigator.
- Patients must have a life expectancy of 12 weeks or more.
- Patients must have an ECOG Performance Status of 0-2.
- Patients must have recovered from acute toxicities of prior treatment. Specifically: \*4 or more weeks must have elapsed since receiving any investigational agent. \*3 or more weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (6 weeks or more for mitomycin or nitrosureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted. \*2 or more 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) or greater. \*Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN. In the case of known liver metastasis, ALT and AST ≤5 x ULN. \*Alkaline phosphatase (ALP) ≤2.5 x ULN. No ULN applies to alkaline phosphatase in the case of known bone metastasis.
- Patients (male and female) must be willing to practice an effective method of birth control during the study.
- Patients must be available for and able to comply with the study-specific blood sampling requirements for pharmacokinetic evaluations.
- Patients or legal representative must understand the investigational nature of this study and sign an 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; any use of trimethoprim, including use for antimicrobial prophylaxis.
- 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 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) greater than or equal to Grade 2 neuromotor or Grade 2 neurosensory) except for abnormalities due to cancer.
- 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).
- 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 :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00100139
Start Date
November 1 2004
End Date
June 1 2010
Last Update
July 4 2011
Active Locations (6)
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1
Cancer Institute of New Jersey - University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States, 08903
2
Universitatsklinikum Essen
Essen, Germany
3
Allgemeines Krankenhaus St. Georg
Hamburg, Germany
4
Academisch Medisch Centrum
Amsterdam, Netherlands