Clinical trial NCT02414100: Patient Derived Cancer Cell Lines in Identifying Molecular Changes in Patients With Previously Untreated Pancreatic Cancer Receiving Gemcitabine Hydrochloride-Based Chemotherapy
Official title: Generation of Patient Derived Pancreatic Cancer Cell Lines to Determine Mechanisms of Chemoresistance
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pancreatic Ductal Adenocarcinoma
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2015-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with treatment naive pancreatic ductal adenocarcinoma (PDA) treated at Thomas Jefferson University or Georgetown University

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Genomic profiles of post-treatment samples with acquired resistance against pre-treatment and germline controls
timeFrame: Up to 5 years
measure: Identification of germline mutations in known cancer genes from whole blood genomic deoxyribonucleic acid, and somatic mutations in conditionally reprogrammed cells derived from pre-treatment and post-treatment (e.g., resistant) tumors
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Jordan Winter, MD
role: PRINCIPAL_INVESTIGATOR
References: