Clinical Trial: CO07204-Phase I/II of Oxaliplatin, Capecitabine & Sorafenib for Advanced Pancreatic & Biliary Carcinoma

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

Official Title: A Phase I/II STudy of Oxaliplatin, Oral Capecitabine and Sorafenib in Patients With Advanced Pancreatic and Biliary Carcinoma"

Brief Summary: This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs approved by the Food and Drug Administration (FDA) for use in the treatment of different cancers. Their use in this exact combination is considered experimental for the treatment of pancreas and biliary tract; however the combination has been tested in a preliminary trial. We are also testing a survey designed. The purpose of this research study is to investigate the chemotherapy drug sorafenib in combination with oxaliplatin and capecitabine chemotherapies for the treatment of pancreas and biliary tract cancers.to help patients report their side effects from chemotherapy treatments.

Detailed Summary:

Primary Objectives

  • To assess the overall safety of sorafenib when administered with "the 2DOC regimen" capecitabine and oxaliplatin in patients with advanced or metastatic pancreas or biliary tract cancers.
  • To define the dose limiting toxicity and maximally tolerated dose of this combination.
  • To assess the clinical response rate (stable, partial and complete responses) of the combination in patients with advanced or metastatic pancreas or biliary tract cancers.

Secondary Objectives

  • To define the time to progression and overall survival for patients treated with this regimen.
  • To evaluate the congruency of the Adverse Events Self-Report Survey in determining patient reported side effects of treatment

Sponsor: University of Wisconsin, Madison

Current Primary Outcome:

  • safety of therapy [ Time Frame: overall study ]
  • efficacy of therapy [ Time Frame: overall study ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Wisconsin, Madison

Dates:
Date Received: March 5, 2008
Date Started: February 2008
Date Completion:
Last Updated: January 19, 2012
Last Verified: January 2012