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A Phase 1 Study of Liposome Encapsulated Docetaxel (LE-DT) in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

A Phase 1 Study of Liposome Encapsulated Docetaxel (LE-DT) in Patients With Advanced Solid Tumors

Liposome Entrapped Doxetaxel (LE-DT) is a novel, proprietary delivery system of docetaxel
developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere®) is an
anti-microtubule agent that prevents cell division by promoting the assembly and
stabilization of microtubules and is used for the treatment of malignancies from breast,
prostate, lung, gastric, head and neck. By removing toxic detergent used in Taxotere®, LE-DT
showed reduced toxicity and comparable therapeutic efficacy in preclinical studies. In
clinic, it is believed that LE-DT will offer advantages to the patient of fewer side effects
at similar doses, and possibly greater effectiveness when used at higher doses. In addition,
routine premedication to prevent hypersensitivity may not be required.

This study is designed to determine the following:

- The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LE-DT.

- The pharmacokinetics of docetaxel following intravenous administration of LE-DT.

- Any anti-tumor effects of LE-DT.

Up to 5 dose levels have been studied.

Inclusion Criteria:

- To be included in this study, patients must meet the following criteria:

- Be ≥18 years of age.

- Have advanced (local and/or metastatic) histologically documented cancer considered
unresponsive to available conventional modalities or treatments.

- Have an ECOG Performance Status of 0-2.

- Have recovered from acute toxicities of prior treatment:

- 4 weeks must have elapsed since receiving any investigational agent.

- 4 weeks must have elapsed since receiving any radiotherapy, or treatment with
cytotoxic or biologic agents (≥6 weeks for mitomycin or nitrosoureas). 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 regimen with
stem cell support.

- 2 weeks must have elapsed since any prior surgery or granulocyte-stimulating
growth factor therapy.

- 12 months must have elapsed since any prior treatment with docetaxel. 5. Be in
adequate condition as evidenced by the following clinical laboratory values:

- Absolute neutrophil count (ANC) ≥1,500/mm3.

- Platelets ≥100,000/mm3.

- Hemoglobin ≥9.0 g/dL.

- Albumin ≥3.0 g/dL.

- Serum creatinine ≤2.0 mg/dL.

- Total bilirubin ≤1.5 x institutional upper limit normal (ULN).

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and
alkaline phosphatase ≤2.5 x ULN.

6. Patients (male and female) must be willing to practice an effective
method of birth control during the study.

7. Patient or legal representative must understand the investigational
nature of this study and sign an Institutional Review Board
(IRB)/Independent Ethics Committee approved written informed consent form
prior to treatment.

Exclusion Criteria:

- Patients are excluded from this study for the following:

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

2. Any active infection requiring parenteral or oral antibiotic treatment.

3. Known infection with human immunodeficiency virus or hepatitis virus.

4. Active heart disease including myocardial infarction or congestive heart failure
within the previous 6 months, symptomatic coronary artery disease, or
arrhythmias currently requiring medication.

5. Known or suspected active central nervous system metastasis. (Patients stable 8
weeks after completion of treatment for central nervous system metastasis are

6. Impending or symptomatic spinal cord compression or carcinomatous meningitis.

7. Having pre-existing clinically significant neuropathy (NCI CTCAE Grade ≥ 2
neuromotor or Grade ≥ 2 neurosensory) except for abnormalities due to cancer.

8. Having failed a docetaxel-containing regimen.

9. Having known non-controllable hypersensitivity to docetaxel or liposomes.

10. Currently receiving any other standard or investigational treatment for cancer
or any other investigational agent for any indication.

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

12. Female patients who are pregnant or breast-feeding.

13. Unwilling or unable to follow protocol requirements.

14. Any condition which, in the Investigator's opinion, deems the patient an
unsuitable candidate to receive study drug.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the tolerability and safety

Outcome Description:

This Phase I, open-label, dose-escalation study was designed to determine the maximum tolerated dose (MTD) of LE-DT in patients with advanced cancer. LE-DT was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

John L Marshall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetowm University Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

May 2010

Related Keywords:

  • Solid Tumors
  • Cancer Patients
  • Neoplasms



Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
TGEN/Scottsdale Clinical Research InstituteScottsdale, Arizona  85258