drugset / Trial / NCT01550510

Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA

NCT01550510

Phase 1/2 Terminated 4 enrolled Thomas Jefferson University
RandomizedParallel-groupOpen-labelTreatment

Summary

This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.

Timeline

Start
2011-12
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 350 mg/m2
Subject Vitamin C Other / unclassified 50 g Intravenous
Subject Vitamin C Other / unclassified 100 g Intravenous

Indications