Neoadjuvant Chemotherapy Followed by Radiation Therapy and Gemcitabine/Sorafenib/Vorinostat in Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02349867|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2015
Last Update Posted : October 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Gemcitabine Drug: Sorafenib Drug: Vorinostat Radiation: 3-Dimensional Conformal Radiation Therapy Radiation: Intensity-Modulated Radiation Therapy Other: RosetteSep Other: DEPfff||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Neoadjuvant Chemotherapy, Followed by Concurrent Chemoradiation With Gemcitabine, Sorafenib, and Vorinostat in Pancreatic Cancer|
|Actual Study Start Date :||January 29, 2015|
|Actual Primary Completion Date :||May 13, 2020|
|Estimated Study Completion Date :||September 30, 2024|
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).
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3D CRT
Radiation: Intensity-Modulated Radiation Therapy
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 Name: negative-selection techniques
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.
Other Name: ApoStream dielectrophoretic field-flow fractionation
- Recommended phase 2 dose and schedule [ Time Frame: 18-36 months ]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.
- Number of participants with adverse events using National Cancer Institute CTCAE v4.0 [ Time Frame: Up to 30 days following last administration of the chemoradiation treatment ]Adverse events using NCI Common Terminology Criteria for Adverse Events, Version 4.0. Adverse events will be listed and summary descriptive statistics will be calculated.
- Tumor response (complete response or partial response) measured using RECIST version 1.1 [ Time Frame: Up to 2 years ]Evaluate number of participants with tumor response measured using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. At the completion of concurrent chemoradiation. Tumor response will be measured as complete response, partial response, stable disease, or tumor progression.
- Surgery [ Time Frame: Up to 2 years ]Number of participants able to undergo resection after neoadjuvant therapy (chemotherapy followed by concurrent chemoradiation)
- R0 Resection rate [ Time Frame: Up to 2 years ]Determine the number of patients able to undergo margin-negative resection following neoadjuvant therapy.
- Progression-free survival (PFS) [ Time Frame: Up to 2 Years ]Number of participants with progression free survival (PFS) defined as the percentage of patients able to undergo margin-negative resection following neoadjuvant therapy
- Overall Survival [ Time Frame: Up to 2 Years ]The number of participants with overall survival (OS) defined as the time from the date of diagnosis until death by any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349867
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Andrew Poklepovic, MD||Massey Cancer Center|