CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 195 enrolled
Drug / intervention
Carboplatin +5 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/NCT02311907
NCT02311907Phase 3Completed
CompareCT.gov

The Use of Glutathione (GSH) for Prevention of Paclitaxel/Carboplatin (TAXOL/CBDCA) Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind Placebo Controlled Study

Alliance for Clinical Trials in Oncology·interventional·Posted Dec 9, 2014·Updated Feb 23, 2017

In Brief

A Phase 3 clinical trial evaluating Carboplatin, Glutathione, and 4 other interventions for Chemotherapeutic Agent Toxicity and 15 related conditions. Completed, enrolled 195 participants across 390 sites.

Detailed Summary

This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapeutic Agent Toxicity, Neuropathy, Neurotoxicity Syndrome, Pain, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2014
Enrollment StartDec 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.6 years ago

Interventions

Carboplatindrug

Given IV, over 30 minutes per planned chemotherapy regimen

Glutathionedrug

Given IV, over 15 minutes, immediately before chemotherapy administration

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV, over 1 or 3 hours, per planned chemotherapy regimen

Placeboother

Given IV

Quality-of-Life Assessmentother

Ancillary studies