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A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Docetaxel Lipid Microsphere for Injection in Cancer Patients Receiving Chemotherapy

Phase 1
18 Years
65 Years
Open (Enrolling)
Advanced Cancer

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Trial Information

A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Docetaxel Lipid Microsphere for Injection in Cancer Patients Receiving Chemotherapy

Docetaxel (currently marketed as Taxotere®), given by intravenous or intraperitoneal
injection, has contributed significantly to the treatment of a variety of malignancies, such
as ovarian, breast, gastric, and non-small-cell lung cancer (NSCLC), as well as head and
neck cancer and some other cancers. In the preclinical, DT-LM showed reduced toxicity
(especially myelosuppression)and comparable therapeutic efficacy. In clinic, it is believed
that DT-LM will offer fewer side effects to the patient at similar doses, and possibly
greater effectiveness when used at higher doses. DT-LM could not only avoid the serious
hypersensitivity reactions caused by Tween 80, but also be stable, safe and convenient for
clinical administration.

This study is designed to determine the following:

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

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

- Any anti-tumor effects of DT-LM.

Controlled trial is also carrying out to reveal the differences in safety, pharmacokinetics
and pharmacodynamics between DT-LM and Taxotere.

Inclusion Criteria:

1. Age > 18 and < 65, with ECOG performance status 0-1,and Life expectancy of more than
3 months.

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

3. 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).

- 4 weeks must have elapsed since any prior surgery.

4. Be in adequate condition as evidenced by the following clinical laboratory values:

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

- Platelets ≥ 80,000/mm3.

- Hemoglobin ≥ 9.0 g/dL.

- WBC ≥ 4,000/mm3.

- Total bilirubin ≤ 2.5 x institutional upper limit normal (ULN).

- Transaminases AST (SGOT) and ALT (SGPT) ≤ 1.5 times ULN or ≤ 5 times ULN (liver

- Serum creatinine ≤ 1.2 times ULN, blood urea nitrogen≤ 1.2 times ULN.

5. both female and male patients must use adequate methods of contraception.

6. 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:

1. Intolerance to any antineoplastic agents belonging to the taxoid family.

2. having failed a docetaxel-containing regimen or Having known non-controllable
hypersensitivity to docetaxel or lipid microsphere.

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

4. Unstable or uncontrolled cardiac disease or hypertension.

5. With other serious internal diseases, uncontrolled infection or uncontrolled

6. With Symptomatic brain metastasis not controlled.

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

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

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

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

11. Unwilling or unable to follow protocol requirements.

12. With history of serious allergic or allergy.

13. Not fit for the clinical trial judged by the investigator.

Type of Study:


Study Design:

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

Outcome Measure:

The safety and tolerability

Outcome Description:

This Phase I, open-label, control,dose-escalation study was designed to determine the maximum tolerated dose (MTD) of DT-LM in patients with advanced cancer. DT-LM 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:

one year

Safety Issue:


Principal Investigator

Xing Tang, Ph.D

Investigator Role:

Study Director

Investigator Affiliation:

Shenyang Pharmaceutical University


China: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

August 2013

Related Keywords:

  • Advanced Cancer
  • Docetaxel
  • Lipid Microsphere
  • Neoplasms
  • Antineoplastic Agents
  • Pharmacologic Actions
  • Therapeutic Uses
  • Neoplasms