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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Withdrawn

Conditions: Stage III Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IV Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Stage IA Pancreatic Cancer

Treatments: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02414100

JT 5543 (Other Identifier)

2013-077 (Other Identifier)

13C.628

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Patient derived cancer cell lines

Description:

Patients receive gemcitabine hydrochloride IV 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 per standard of care. Tissue and blood samples are collected for genetic analysis via sequencing.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Cytology Specimen Collection Procedure