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Clinical Trial Details

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Brief Title Genetic Analysis-Guided Dosing of FOLFIRABAX in Treating Patients With Advanced Gastrointestinal Cancer
Official Title A Genotype-Guided Dosing Study of FOLFIRABRAX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies
Principal Investigator Sharma, Manish
Brief Summary This phase I/II trial studies the side effects of genetic analysis-guided dosing of paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRABAX) in treating patients with gastrointestinal cancer that has spread to other parts of the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.
Gender Both
Ages 18 Years
Enrollment 51
Accepts Healthy Volunteers No
Lead Sponsor University of ChicagoOther
Collaborator National Cancer Institute (NCI)NIH
Study Design Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1/Phase 2
Study Type Interventional
Contact Name Manish R. Sharma
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Adenocarcinoma of Unknown Primary
Detail for Health Professional (on clinicaltrials.gov)
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