drugset
drugset / Trial / NCT04361708

Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies

NCT04361708 ↗

Phase 1 Recruiting 54 enrolled University of Chicago
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin/folinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin/folinic acid is a vitamin to make 5-FU work well).

Timeline

Start
2020-05-08
Primary completion
2026-06
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 25 mg Other
Subject Docetaxel Small molecule 37.5 mg Other
Subject Irinotecan Small molecule 45 mg/m2 Other
Subject Irinotecan Small molecule 105 mg/m2 Other
Subject Irinotecan Small molecule 120 mg/m2 Other
Background Leucovorin Small molecule 400 mg/kg Other
Background Oxaliplatin Small molecule 85 mg/kg Other
Background fluorouracil Small molecule — Intravenous

Indications

gastroesophageal junction adenocarcinoma pancreatic adenocarcinoma