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A Randomized Two-Period Crossover, Clinical Bioequivalence Study Comparing the Pharmacokinetics of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation Versus Taxol® in Patients With Advanced Cancer

Phase 1
18 Years
Not Enrolling

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Trial Information

A Randomized Two-Period Crossover, Clinical Bioequivalence Study Comparing the Pharmacokinetics of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation Versus Taxol® in Patients With Advanced Cancer

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 determine which drug is administered first. A single dose of LEP-ETU or
Taxol (Cycle A) will be administered, followed 3 weeks later by a single dose of the other
drug (Cycle B). Blood samples for PK analysis will be taken before, during, and after the
infusion of each drug. Following successful completion of both Cycles in this study,
patients may be eligible for additional cycles of treatment with LEP-ETU in the LEP-ETU-102B
extension study.

Inclusion Criteria:

- 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 Criteria:

- Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer

- 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 for a list of such agents).

- Requiring immediate palliative treatment of any kind including surgery and/or

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine whether LEP-ETU and Taxol are bioequivalent.


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

June 2010

Related Keywords:

  • Neoplasm
  • Neoplasm
  • Cancer
  • NeoPharm
  • Liposomes
  • Taxol
  • Paclitaxel
  • Anti-cancer
  • Advanced neoplasm
  • Advanced cancer
  • Chemotherapy
  • Refractory cancer
  • Metastatic cancer
  • Neoplasms



Cancer Institute of New Jersey - University of Medicine and Dentistry of New Jersey New Brunswick, New Jersey  08903