Vorinostat Plus Radiation Therapy in Pancreatic Cancer
To determine the maximum tolerated dose (MTD) of vorinostat + radiation therapy (RT) in patients with locally advanced pancreatic cancer (LAPC).
- To assess the efficacy of vorinostat + RT in patients with LAPC as estimated by median overall survival.
- 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.
- 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.
- To correlate serum cytokine levels with symptoms and treatment outcomes.
|Pancreatic Cancer||Radiation: Chemoradiation (Radiation Therapy) Drug: Vorinostat||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Vorinostat and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer|
- Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation [ Time Frame: Toxicity assessment at 6 weeks following chemoradiation (6 weeks) ]MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).
|Study Start Date:||May 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Vorinostat + Radiation Therapy
Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
Radiation: Chemoradiation (Radiation Therapy)
Dose of 50.4 Gy in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
Other Names:Drug: Vorinostat
Starting Dose of 200 mg orally once daily, Monday to Friday, Weeks 1 to 6.
The Study Drugs:
Vorinostat is designed to interfere with the growth of cancer cells.
Study Drug Dose Level:
If you are found to be eligible to take part in the study, you will begin receiving vorinostat. The dose you receive will be based on how many participants have been enrolled before you, and on the safety data available. The first group of 3 enrolled participants will be given low doses of vorinostat. If no intolerable side effects occur, the next group of 3 will be enrolled at a higher dose level. The study doctor will tell you what dose you will be receiving and how it compares to the doses other participants have received. Up to 3 dose levels will be tested.
Study Drug Administration:
On each day that you receive radiation, you will take vorinostat (as a capsule taken by mouth) in the morning with food.
You will receive radiation once a day on Monday through Friday, except for holidays. This schedule will be continued for 5 1/2 weeks or 28 doses total. Each radiation treatment will usually last about 10-15 minutes.
After completing radiation therapy, you will come back for a follow-up visit about 6-12 weeks later.
Length of Study:
You will remain on study for up to 5 1/2 weeks. You will be taken off-study early if the disease gets worse or intolerable side effects occur.
This is an investigational study. Vorinostat is FDA approved and commercially available. The use of vorinostat for pancreatic cancer and in combination with radiation is investigational. At this time, this combination is being used in research only.
Up to 37 patients will take part in the study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831493
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sunil Krishnan, MD||UT MD Anderson Cancer Center|