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Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01186731
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : September 12, 2012
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Brief Summary:

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 removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose to induce greater effectiveness of LE-DT. In addition, docetaxel has shown positive activity of protein bound taxane therapy in treating patients with pancreatic cancer. The current Phase II study is designed to accomplish the following objectives:

  1. Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every three weeks in pancreatic cancer patients with locally advanced or metastatic disease
  2. To evaluate the progression-free survival and overall survival
  3. To correlate secreted protein acid rich in cysteine expression with tumor response
  4. To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention as well as myelotoxicity
  5. To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic endpoints, including toxicities.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Liposome Entrapped Docetaxel (LE-DT) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Multicenter, Open-Label, Phase II Study of LE-DT for Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Study Start Date : April 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Liposome Entrapped Docetaxel (LE-DT) Drug: Liposome Entrapped Docetaxel (LE-DT)
110 mg/m2 (IV)in vein on day 1 of each 21 day cycle , 6 cycles, until progression or unacceptable toxicity
Other Names:
  • Liposomal Docetaxel
  • LE-DT

Primary Outcome Measures :
  1. Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level [ Time Frame: 1 year ]
    Measurable disease response will be assessed by radiographic method, CT or MRI, along with serum CA 19-9 after completed 2, 4 and 6 cycle.

Secondary Outcome Measures :
  1. SPARC tumor expression following the treatment of LE-DT at 110 mg/m2 dose level [ Time Frame: 1 year ]
    SPARC tumor expression will be assessed as a potential predictor of tumor response

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is 18 years or older, male and female.
  2. Patient has histopathologically confirmed diagnosis of adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded. Biopsy sample must be available for SPARC assay.
  3. Patients must have clinical or radiographic evidence of locally advanced or metastatic pancreatic cancer with measurable disease.
  4. Male or non-pregnant and non-lactating female:

    • If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug.
    • If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
  5. Patient can be newly-diagnosed without prior treatment or have failed initial adjuvant treatment with either gemcitabine, 5-FU or capecitabine with or without radiation therapy.
  6. Patient has the following blood counts at baseline:

    • ANC greater than or equal to 1500 per uL
    • Platelets greater than or equal to 100000 per uL
    • Hgb greater than or equal to 9 g per dL
  7. Patient has the following blood chemistry levels at baseline:

    • AST (SGOT), ALT (SGPT) less than or equal to 2.5 times of the upper limit of normal range (ULN), unless liver metastases are present, then less than or equal 5 times of the ULN is allowed
    • Bilirubin less than or equal to 1.5 times of the ULN
    • Serum creatinine less than or equal to 1.5 times of the ULN or calculated clearance greater than or equal to 60 mL/min for patients with serum creatinine levels above the institutional normal value.
  8. Patient has acceptable coagulation profile as indicated by a Prothrombin time (PT) and Partial Thromboplastin Time (PTT) within normal limits (plus or minus 15%) unless explained by the use of anticoagulants
  9. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  10. Patient has one or more metastatic lesions or locally advanced primary tumor measurable by CT or MRI.
  11. Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

  1. Patient has known brain metastases.
  2. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  3. Patient has known infection with HIV, hepatitis B, or hepatitis C.
  4. Patient has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
  5. Patient who have received any other treatment for pancreatic cancer including radiotherapy, chemotherapy or any investigational therapy with the exception of initial adjuvant treatment including either gemcitabine, 5-FU or capecitabine with or without radiation therapy
  6. Patient has a history of allergy or hypersensitivity to the study drug.
  7. Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
  8. Patient has pre-existing peripheral neuropathy of Grade >1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
  9. Patient is unwilling or unable to comply with study procedures.
  10. Patient is enrolled in any other clinical or investigational trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01186731

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United States, District of Columbia
Lombardi Cancer Center, Georgetown University Medical Center
Washington, District of Columbia, United States, 20007-2197
Sponsors and Collaborators
INSYS Therapeutics Inc
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Principal Investigator: John L Marshall, M.D. Lombardi Cancer Center, Georgetown University Medical center

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Responsible Party: INSYS Therapeutics Inc Identifier: NCT01186731    
Other Study ID Numbers: Protocol LE-DT 202
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: August 2012
Keywords provided by INSYS Therapeutics Inc:
SPARC (secreted protein acid rich in cysteine)
serum Carbohydrate Antigen CA 19-9
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action