Neoadjuvant Chemotherapy Followed by Radiation Therapy and Gemcitabine/Sorafenib/Vorinostat in Pancreatic Cancer

Summary

Determine the doses and schedule appropriate for phase 2 study of sorafenib and vorinostat with concurrent gemcitabine and radiation therapy (RT) as neoadjuvant treatment of pancreatic cancer following chemotherapy. Recommended phase II dose RP2Ds and schedule of sorafenib and vorinostat defined as the doses and schedule that are the same as or less than the maximum tolerated dose (MTD) and schedule.

Conditions

• Pancreatic Adenocarcinoma
• Stage IA Pancreatic Cancer
• Stage IB Pancreatic Cancer
• Stage IIA Pancreatic Cancer
• Stage IIB Pancreatic Cancer
• Stage III Pancreatic Cancer
• Recurrent Pancreatic Carcinoma

Interventions

DRUG

Gemcitabine

Given IV

DRUG

Sorafenib

Given PO

DRUG

Vorinostat

Given PO

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D CRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

RosetteSep

Circulating tumor cells (CTCs) will be captured and analyzed, when detected. Pancreatic cancer has been a difficult tumor in which to detect CTCs (41). Utilization of techniques that do not require cell surface marker expression will be explored. Samples will either be analyzed by negative-selection techniques (RosetteSep). Peripheral blood samples will be collected at several time-points for CTC enumeration and to evaluate CD95 density.

OTHER

DEPfff

Circulating tumor cells (CTCs) will be captured and analyzed, when detected. Pancreatic cancer has been a difficult tumor in which to detect CTCs (41). Utilization of techniques that do not require cell surface marker expression will be explored. Samples will either be analyzed by with the ApoStream dielectrophoretic field-flow fractionation (DEPfff) enrichment device. Peripheral blood samples will be collected at several time-points for CTC enumeration and to evaluate CD95 density.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Virginia Commonwealth University

  lead OTHER

Principal Investigators

• Andrew Poklepovic, MD · Massey Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-29

Primary Completion

2020-05-13

Completion

2022-05-13

FDA Drug

Yes

Countries

• United States

Study Locations