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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT02349867
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Given IV
  • Sorafenib — DRUG
    Given PO
  • Vorinostat — DRUG
    Given PO
  • 3-Dimensional Conformal Radiation Therapy — RADIATION
    Undergo 3D CRT
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • RosetteSep — OTHER
    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.
  • DEPfff — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 29, 2015
Status verified
Sep 2022
Primary completion
May 13, 2020
Completion
May 13, 2022

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (chemotherapy, chemoradiation)
    Participants receive gemcitabine IV infusion over 30 minutes (200 mg/m2 weekly) x 6, concurrent administration of oral sorafenib and oral vorinostat (both per dose-escalation schema), and concurrent RT( 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy) administered at 1.8-Gy fractions to a total dose of 50.4 Gy over 5 ½ weeks (28 daily fractions).

Primary Outcome Measure

Recommended phase 2 dose and schedule [ Time Frame: 18-36 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Richmond, VA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Virginia Commonwealth University/Massey Cancer Center· Richmond, VA

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