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Trial Summary

Protocol No.LCCC1317
StatusOPEN TO ACCRUAL
Principal InvestigatorO'Neil, Bert
ScopeNational
PhasePhase II
Age GroupAdult
TitleGenotype-directed Phase II Study of Irinotecan Dosing in Metastatic Colorectal Cancer (mCRC) Patients Receiving FOLFIRI + Bevacizumab
DescriptionThe purpose of this research study is to determine if dosing irinotecan based on genotype is effective and safe for patients with colon cancer. Patient genotype will be determined from a small sample of blood and a laboratory test or "assay" performed at UNC Laboratories. For the purpose of this study, this assay is new and considered to be "investigational". This means that the genotype assay used in this study has not yet been approved by the FDA for determining irinotecan dose levels in patients with colon cancer.
Key EligibilityTo be eligible for this trial, patients must:
  • Histological or cytological documentation of adenocarcinoma of the colon or rectum
  • Willing to undergo UGT1A1 genotyping
For a full list of eligibility criteria, please visit ClinicalTrials.gov.
Applicable Disease SitesColon and Rectal Cancer
Participating InstitutionsIU Health Arnett
  • IU Health Arnett Cancer Care Clinic
Indiana University (IU)
  • Eskenazi Hospital
  • Indiana University Hospital / IU Simon Cancer Center
  • Spring Mill Medical Center
Treatment TypeTreatment