drugset / Trial / NCT02366819

Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer

NCT02366819

NaSingle-groupOpen-labelTreatment

Summary

This pilot clinical trial studies genetic analysis-guided irontecan hydrochloride dosing of modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin (mFOLFIRINOX) in treating patients with gastroesophageal or stomach cancer that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin, 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. Leucovorin calcium may also help fluorouracil work better. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.

Timeline

Start
2014-12-11
Primary completion
2026-06-08
Completion
2026-06-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 90 mg/m2 Intravenous
Subject Irinotecan Small molecule 135 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous