Last updated on February 2020

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


Brief description of study

This is a phase 1 study of concurrent chemoradiation using a regimen of sorafenib and vorinostat with gemcitabine and radiation following chemotherapy in patients with pancreatic cancer to find the RP2D of the concurrent chemoradiation combination. A traditional 3+3 dose-escalation design will be conducted for the sorafenib and vorinostat dose escalation. Adenocarcinoma of the pancreas without distant metastasis that has been treated with 1 prior therapy (not including radiation) encompassing at least 2 months. Adequate hematologic, hepatic, and renal function. Ability to take oral medication. To 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.

Detailed Study Description

To 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. RP2Ds and schedule of sorafenib and vorinostat defined as the doses and schedule that are the same as or less than the MTDs and schedule.

This is a dose-escalation trial employing a standard "3+3" schema of sorafenib and vorinostat.

The sample size with a total of 5 proposed dose levels and starting at dose level 1B for dose escalation, the number of patients evaluable for DLT ranges from 4-30. To account for about 20% patients anticipated to subsequently be found to be not evaluable for toxicity, authorization for enrollment of 36 patients will be sought from regulatory authorities. Likely scenarios probably involve 12-24 evaluable patients and therefore 15-30 patients will be enrolled in the study.

After completion of study treatment, patients are followed up for 30 days and then every 2-3 months up to 2 years or until death.

Clinical Study Identifier: NCT02349867

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