Pancreatic Neoplasms Clinical Trial
Official title:
A Phase I/II STudy of Oxaliplatin, Oral Capecitabine and Sorafenib in Patients With Advanced Pancreatic and Biliary Carcinoma"
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.
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
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