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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT01186731
First received: August 18, 2010
Last updated: September 11, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: Liposome Entrapped Docetaxel (LE-DT)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by INSYS Therapeutics Inc:

Primary Outcome Measures:
  • Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • SPARC tumor expression following the treatment of LE-DT at 110 mg/m2 dose level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    SPARC tumor expression will be assessed as a potential predictor of tumor response


Enrollment: 40
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186731

Locations
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
Investigators
Principal Investigator: John L Marshall, M.D. Lombardi Cancer Center, Georgetown University Medical center
  More Information

No publications provided

Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT01186731     History of Changes
Other Study ID Numbers: Protocol LE-DT 202
Study First Received: August 18, 2010
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by INSYS Therapeutics Inc:
SPARC (secreted protein acid rich in cysteine)
serum Carbohydrate Antigen CA 19-9

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014