Patient Derived Cancer Cell Lines in Identifying Molecular Changes in Patients With Previously Untreated Pancreatic Cancer Receiving Gemcitabine Hydrochloride-Based Chemotherapy



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/12/2016
Start Date:December 2013
Contact:Jordan Winter, MD
Phone:215-955-9402

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Generation of Patient Derived Pancreatic Cancer Cell Lines to Determine Mechanisms of Chemoresistance

This pilot research trial studies patient derived cancer cell lines in identifying molecular
changes in patients with previously untreated pancreatic cancer and are receiving
gemcitabine hydrochloride-based chemotherapy. Cell lines refer to samples taken from the
patient's tumor to grow for many months or years in a laboratory, and can therefore be
studied scientifically. Studying cell lines in the laboratory may help doctors understand
the genetic changes that occur to the tumor during chemotherapy that allows the tumor to
resist or grow despite treatment.

PRIMARY OBJECTIVES:

I. Compare the genetic profile of the tumor after progression has occurred, to the tumor
prior to treatment.

SECONDARY OBJECTIVES:

I. Additional molecular patterns, beyond genetics, will be analyzed, including ribonucleic
acid (RNA) and protein expression.

OUTLINE:

Tissue and blood samples are collected for genetic analysis via sequencing from patients
receiving gemcitabine hydrochloride intravenously or gemcitabine hydrochloride and
paclitaxel albumin-stabilized nanoparticle formulation. Chemotherapy is not part of the
protocol. Per standard of care, patients receive gemcitabine hydrochloride (IV) the first 3
of 4 weeks (qw 3/4 wk) or gemcitabine hydrochloride and paclitaxel albumin-stabilized
nanoparticle formulation IV qw 3/4 wk in the absence of disease progression or recurrence.

Inclusion Criteria:

1. Suspected or confirmed pancreatic adenocarcinoma, any stage

2. >18 years of age

3. No prior systemic chemotherapy for pancreatic cancer, or currently undergoing
first-line treatment for pancreatic cancer, or completed only first-line treatment
for pancreatic cancer

4. A plan to undergo gemcitabine-based chemotherapy at Thomas Jefferson or a
collaborating institution

5. Abdominal/pelvic CT scan or MRI within 4 months of the study

6. Signed study-specific informed consent

Exclusion Criteria:

1. Pregnancy

2. Prior systemic chemotherapy for pancreatic cancer

3. Gender/Minority/Pediatric Inclusion for Research
We found this trial at
1
site
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Jordan Winter, MD
Phone: 215-955-9402
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