Clinical Trial: Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Study of Panobinostat (LBH589) Given in Combination With Bortezomib (Velcade) in Patients With Pancreatic Cancer Progressing on Gemcitabine Therapy Alone or Gemcitabine in Combination

Brief Summary: Cancer results from multiple mutations which cause cells to grow uncontrolled. It therefore may be necessary to inhibit several oncogenic targets to affect cancer cell growth. Studies have shown that panobinostat (LH589) causes a wide range of effect on endothelial cells that lead to inhibition of tumor angiogenesis (a fundamental step in the transition of tumors from a dormant state to a malignant one). Bortezomib triggers cell death in pancreatic cancer cells but the mechanism is not well defined but has been determined to be cytostatic. Combining these two drugs may work together in the treatment of pancreatic cancer.

Detailed Summary:
Sponsor: Masonic Cancer Center, University of Minnesota

Current Primary Outcome: Progression-Free Survival [ Time Frame: Up to 1 Year ]

Median number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.


Original Primary Outcome: Determine progression-free survival [ Time Frame: 3 months, 6 months, 1 year ]

Current Secondary Outcome:

  • Number of Participants by Tumor Response [ Time Frame: Up to 1 Year ]
    Number of patients whose tumor has responded to study therapy is determined using Response Evaluation Criteria In Solid Tumors. Progressive Disease (PD) is assessed if the sum of the diameters has increased by ≥ 20% and ≥ 5 mm from nadir (including baseline if it is the smallest sum). Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.
  • Duration of Response [ Time Frame: Up to 1 Year ]
    Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed Complete or Partial Response as defined by RECIST criteria).


Original Secondary Outcome:

  • Determine tumor response rate [ Time Frame: 3 months, 6 months, 1 year ]
  • Determine duration of response [ Time Frame: 3 months, 6 months, 1 year ]
  • Characterize the quantitative and qualitative toxicities [ Time Frame: Day 1 through 30 days post treatment ]


Information By: Masonic Cancer Center, University of Minnesota

Dates:
Date Received: January 25, 2010
Date Started: September 2010
Date Completion:
Last Updated: November 6, 2012
Last Verified: November 2012