Status:
COMPLETED
Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
INSYS Therapeutics Inc
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Patient is 18 years or older, male and female.
- 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.
- Patients must have clinical or radiographic evidence of locally advanced or metastatic pancreatic cancer with measurable disease.
- 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.
- 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.
- 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
- 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.
- 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
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient has one or more metastatic lesions or locally advanced primary tumor measurable by CT or MRI.
- 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
- Patient has known brain metastases.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has known infection with HIV, hepatitis B, or hepatitis C.
- 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.
- 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
- Patient has a history of allergy or hypersensitivity to the study drug.
- 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.
- Patient has pre-existing peripheral neuropathy of Grade \>1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
- Patient is unwilling or unable to comply with study procedures.
- Patient is enrolled in any other clinical or investigational trial.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01186731
Start Date
April 1 2010
End Date
December 1 2011
Last Update
September 12 2012
Active Locations (1)
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1
Lombardi Cancer Center, Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007-2197