A PHASE I STUDY OF A COMBINATION OF YTTRIUM-90 LABELED ANTI-CEA ANTIBODY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research study is to find the highest dose of the drug gemcitabine that can be given with an investigational drug called a radioactive antibody (Y-90 anti-CEA) without causing unmanageable side effects, to treat subjects with advanced cancer (disease that has spread to distant parts of the body) that produces a substance called CEA (carcinoembryonic antigen). An additional purpose is to estimate the radiation dose of Y-90 anti CEA to the whole body, organs and tumor. For most advanced cancers (disease that has spread to distant parts of the body), treatment options are limited if surgery or radiation is no longer possible. Therapy for the entire body is usually the treatment strategy of choice. However, in most cases response rates using this strategy are limited and relatively short lived. Experimental treatments are therefore necessary. CEA is a protein that is present in a variety of cancers. In earlier studies, an antibody to CEA was shown to find and attach to tumors that contain CEA. In some cases attaching a radioactive particle to anti-CEA antibody can direct enough radioactivity to the tumor to help shrink it. In most cases, however, it is difficult to direct enough radioactivity to shrink the tumor without causing severe side effects such as decreased blood counts. It is possible that giving both a radioactive antibody and a chemotherapy drug may lead to more effective treatment. Clinical trials have shown that combinations of radiation and chemotherapy interact with the tumor to improve treatment results in a variety of cancers. Gemcitabine is a chemotherapy drug that has shown evidence of strong interaction with radiation both in the laboratory and in patients.