CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 362 enrolled
Drug / intervention
calcium gluconate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01099449
NCT01099449Phase 3Completed

A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity

Alliance for Clinical Trials in Oncology·interventional·Posted Apr 7, 2010·Updated Nov 3, 2022

In Brief

A Phase 3 clinical trial evaluating calcium gluconate, magnesium sulfate, and 2 other interventions for Chemotherapeutic Agent Toxicity and 3 related conditions. Completed, enrolled 362 participants across 405 sites in 2 countries.

Detailed Summary

RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity. PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2010
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.2 years ago

Interventions

calcium gluconatedrug

Given IV

magnesium sulfatedrug

Given IV

placeboother

Given IV

oxaliplatindrug