drugset / Trial / NCT00831493

Vorinostat Plus Radiation Therapy in Pancreatic Cancer

NCT00831493

NaSingle-groupOpen-labelTreatment

Summary

Primary Endpoint: To determine the maximum tolerated dose (MTD) of vorinostat + radiation therapy (RT) in patients with locally advanced pancreatic cancer (LAPC). Secondary Endpoints: 1. To assess the efficacy of vorinostat + RT in patients with LAPC as estimated by median overall survival. 2. To determine the radiological response as assessed by regular computer tomography (CT) and/or dynamic contrast enhanced computer tomography (DCE-CT) among patients treated with vorinostat and RT. 3. To evaluate the occurrence of symptoms and correlate to disease progression and tolerance to treatment using the MD Anderson Symptom Inventory-Gastrointestinal Module (MDASI-GI) self-reporting tool. 4. To correlate serum cytokine levels with symptoms and treatment outcomes.

Timeline

Start
2009-05
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Vorinostat Small molecule 200 mg Oral