Clinical Trial: Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Gemcitabine, Oxaliplatin in Combination With Panitumumab in Kras/B-raf Wild-Type Unresectable or Metastatic Biliary Track and Gallbladder Cancer

Brief Summary: The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have previously not received chemotherapy. This study will also examine the potential toxicities, progression-free and overall survival in this population.

Detailed Summary:
Sponsor: University of Rochester

Current Primary Outcome: The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. [ Time Frame: end of cycle 2 of treatment ]

Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.


Original Primary Outcome: To determine the radiographic response rate of GEMOX-Panitumumab (GEMOX-P) in chemotherapy naïve KRAS/ BRAF wild type stage IV BTC [ Time Frame: Evaluation at every 8 weeks and thereafter. Responses must be ]

Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.


Current Secondary Outcome:

  • Median Progression Free Survival [ Time Frame: time to cancer progression or death ]
    Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
  • Median Overall Survival [ Time Frame: enrollment until date of death ]
    Death from any cause was used.
  • The Number of Participants Who Experience an Adverse Event [ Time Frame: baseline to study completion ]
    Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event


Original Secondary Outcome: Evaluate the toxicities of GEMOX-P regimen in this population. Evaluate the preliminary efficacy of GEMOX-P regimen including progression free survival, and overall survival in this population. [ Time Frame: Patients will be followed until death ]

Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event


Information By: University of Rochester

Dates:
Date Received: August 9, 2010
Date Started: December 2010
Date Completion:
Last Updated: July 7, 2016
Last Verified: July 2016