drugset / Trial / NCT00449137

Arsenic Trioxide, Fluorouracil, and Leucovorin in Treating Patients With Stage IV Colorectal Cancer That Has Relapsed or Not Responded to Treatment

NCT00449137

Phase 1 Completed 13 enrolled University of Miami
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide may help fluorouracil and leucovorin work better by making tumor cells more sensitive to the drugs. Giving arsenic trioxide together with fluorouracil and leucovorin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide and fluorouracil when given together with leucovorin in treating patients with stage IV colorectal cancer that has relapsed or not responded to treatment.

Timeline

Start
2005-06
Primary completion
2010-02
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject arsenic trioxide Small molecule Intravenous
Subject fluorouracil Small molecule 1600 mg/m2 Intravenous
Background Leucovorin Small molecule 500 mg/m2 Intravenous

Indications