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Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Multicenter, Open-Label, Phase II Study of LE-DT for Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT01186731•INSYS Therapeutics Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

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.

Locations (1)

Lombardi Cancer Center, Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Key Dates

Start Date

April 1, 2010

Primary Completion Date

April 1, 2011

Completion Date

December 1, 2011

Last Updated

September 12, 2012

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

Liposome Entrapped Docetaxel (LE-DT)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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