Efficacy And Safety Study Of LE-DT To Treat Locally Advanced Or Metastatic Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Liposome Entrapped Docetaxel (LE-DT)

Protocol LE-DT 202

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-08-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-09-11
First Submitted that Met QC Criteria 2010-08-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-09-12
First Posted (ESTIMATED) 2010-08-23	Results First Posted N/A	Last Verified 2012-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level	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.	1 year

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: John L Marshall, M.D., Lombardi Cancer Center, Georgetown University Medical center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record