2007

Mayo Clinic Briefings

North Central Cancer Treatment Group Enrolling Patients in Study of Small Bowel Cancer First-Line Treatments

Patients who have unresectable, advanced small bowel adenocarcinoma are now eligible to enroll in a national multicenter prospective trial of first-line therapy at Mayo Clinic Rochester.

Coordinated by the North Central Cancer Treatment Group, the study is a phase 2 investigation to determine the efficacy of dose levels of an experimental combination chemotherapy regimen tailored to each patient's genotype of a drug metabolizing enzyme, UGT1A1.

The combination consists of the drugs irinotecan, oxaliplatin, and capecitabine. This approach is being used because each of the drugs in the combination works in different ways to stop or retard the growth of tumor cells, and data suggest that treating cancer with multiple therapeutic strategies may kill more tumor cells. The study investigators also believe that determining the drug dose according to genotype allows the drugs to be combined more safely and effectively.

Participants will be assigned to 1 of 3 groups on the basis of genotype. Each group will be given a distinct variant of the combined chemotherapy drugs every 3 weeks for up to a total of 12 therapy sessions over approximately 9 months. Blood and serum samples are collected for genotyping, celiac disease screening, and research purposes, including translational and pharmacologic studies. Patients must have measurable disease as determined by the Response Evaluation Criteria in Solid Tumors.

Among enrollment criteria are requirements that patients be at least 18 years old and have histologically confirmed small bowel adenocarcinoma that is metastatic, unresectable, or locally advanced.