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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

John L Marshall, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lombardi Cancer Center, Georgetown University Medical center

Authority:

United States: Food and Drug Administration

Study ID:

Protocol LE-DT 202

NCT ID:

NCT01186731

Start Date:

April 2010

Completion Date:

December 2011

Related Keywords:

  • Pancreatic Cancer
  • SPARC (secreted protein acid rich in cysteine)
  • serum Carbohydrate Antigen CA 19-9
  • Pancreatic Neoplasms

Name

Location

Lombardi Cancer Center, Georgetown University Medical CenterWashington, District of Columbia  20007