Trial · Interventional

CompletedPhase 3Results postedRegistry data

Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer

NCTNCT02311907Other idN08CAOther idNCI-2011-01965Other idCDR0000654097Other idU10CA037404

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 195 participants (actual)
Sponsor: Alliance for Clinical Trials in Oncology · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Dec 2009
Primary completion: Aug 2012
Completion: Aug 2012
First posted: 9 Dec 2014 (estimated)
Last update posted: 23 Feb 2017
Conditions: Chemotherapeutic 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

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20092010201120122013

Ph 3
Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
NCT02311907
Dec 2009 to Aug 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CarboplatinDrug
GlutathioneDrug
Laboratory Biomarker AnalysisOther
PaclitaxelDrug
PlaceboOther
Quality-of-Life AssessmentOther

Arms2

Experimental
Arm I (glutathione, carboplatin)
Patients receive glutathione intravenously (IV) over 15 minutes, paclitaxel\* IV over 1 or 3 hours depending on planned dose cycle length and carboplatin IV over 30 minutes.
Placebo comparator
Arm II (placebo, paclitaxel)
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 1 or 3 hours depending on planned dose cycle length and carboplatin IV over 30 minutes.

Primary outcomes1

Outcomes the sponsor listed as primary.

Paclitaxel/Carboplatin (PC) Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer (EORTC), Quality of Life (QLQ), Chemotherapy Induced Peripheral Neuropathy 20 (CIPN20)).
Time frame · Every 28 day cycle, up to 6 cycles.
Registry description
The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale (higher scores indicated less symptoms and better quality of life). Generalized linear models (repeated measures analysis of variance \[ANOVA\] if data are complete) will be used to compare the CIPN between Glutathione (GSH) and placebo arms.

Secondary outcomes(8)

Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)
Time frame · Up to 1 year
Registry description
A log-rank test and a Kaplan-Meier curve will be used to compare the recurrence free survival between GSH and placebo arms (for ovarian/fallopian tube/primary peritoneal patients only).
Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.
Time frame · Baseline to 1 year
Registry description
Quality of life was measured by FACT-O (on a 0 to 100 scale, higher scores represent better life quality) from baseline and at the end of TAXOL/CBDCA. The change in Quality of Life was calculated as the difference between baseline measure and end of treatment measure (with range from -100 to 100). A negative change represents a worsening in QOL from baseline to one year. Abbreviations used: Change from Baseline (chg from bsl)
Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms
Time frame · Up to 1 year
Registry description
Descriptive statistics will be used to describe TAXOL/CBDCA acute pain syndrome incidence/severity between GSH and placebo arms. Pain was scored on a scale from 0-10, where 0 = 'No aches or pains' and 10 = 'Aches or pains as bad as can be.'
Percentage of Patients Delaying PC Chemotherapy Secondary to PN
Time frame · Up to 1 year
Registry description
Patients delaying TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.
Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN
Time frame · Up to 1 year
Registry description
Proportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms.
Percentage of Patients With Grade 2+ and Grade 3+ Paclitaxel/Carboplatin-induced (PCI) Peripheral Neuropathy (PN) According to the Common Terminology Criteria for Adverse Events (CTCAE) Neuropathy Scale
Time frame · Up to 1 year
Registry description
Proportion of grade 2+ and grade 3+ chemotherapy induced peripheral neuropathy (CIPN) at any time during or at the end of the TAXOL/CBDCA based chemotherapy between GSH and placebo arms. Neuropathy scale has grades 1 through 5 (1-mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening and Grade 5 Death related to AE).
Times to Onset of CTCAE Grade 2+ PN
Time frame · Up to 1 year
Registry description
Compare time to grade 2+ CIPN between GSH and placebo arms.
Times to Onset of CTCAE Grade 3+ PN
Time frame · Up to 5 years from registration
Registry description
Time to grade 3+ CIPN between GSH and placebo arms.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Every 28 day cycle, up to 6 cycles.

Paclitaxel/Carboplatin (PC) Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer (EORTC), Quality of Life (QLQ), Chemotherapy Induced Peripheral Neuropathy 20 (CIPN20)).

Group	Value (Units on a scale 1-100)	Spread
A (Glutathione, Carboplatin)	83.7	0.89
B (Placebo, Paclitaxel)	82.1	0.93

Secondary and other outcome results(7)

Secondary outcomeMedian· Up to 1 year

Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)

Group	Value (Median survival time in days)
A (Glutathione, Carboplatin)	NA
B (Placebo, Paclitaxel)	NA

Secondary outcomeMedian· Baseline to 1 year

Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.

Group	Value (units on a scale)
A (Glutathione, Carboplatin)	-14.3
B (Placebo, Paclitaxel)	-8.9

Secondary outcomeMedian· Up to 1 year

Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms

Group	Value (units on a scale)
A (Glutathione, Carboplatin)	2.0
B (Placebo, Paclitaxel)	2.0

Secondary outcomeNumber· Up to 1 year

Percentage of Patients Delaying PC Chemotherapy Secondary to PN

Group	Value (Percentage of participants)
A (Glutathione, Carboplatin)	1.1
B (Placebo, Paclitaxel)	0

Secondary outcomeNumber· Up to 1 year

Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN

Group	Value (percentage of participants)
A (Glutathione, Carboplatin)	2.1
B (Placebo, Paclitaxel)	1.1

Secondary outcomeNumber· Up to 1 year

Percentage of Patients With Grade 2+ and Grade 3+ Paclitaxel/Carboplatin-induced (PCI) Peripheral Neuropathy (PN) According to the Common Terminology Criteria for Adverse Events (CTCAE) Neuropathy Scale

Group	Value (percentage of participants)
A (Glutathione, Carboplatin)	38.3
B (Placebo, Paclitaxel)	33.0

Secondary outcomeMedian· Up to 1 year

Times to Onset of CTCAE Grade 2+ PN

Group	Value (days)	Spread
A (Glutathione, Carboplatin)	140	18.5
B (Placebo, Paclitaxel)	234	26.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
A (Glutathione, Carboplatin)Quality-of-Life Assessment: Ancillary studies	–	7 / 94	64 / 94
B (Placebo, Paclitaxel)Quality-of-Life Assessment: Ancillary studies	–	1 / 91	62 / 91

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Scheduled to undergo treatment with TAXOL at 150-200 mg/m2 and CBDCA at area under the curve (AUC) = 5-7 every 21 or 28 days for at least 12 weeks; alternatively, paclitaxel can be prescribed at 80 mg/m2 weekly for at least 12 weeks, with the same CBDCA dose of AUC = 5-7 every 21 days; additional chemotherapy agents are allowed (bevacizumab, etoposide, etc) per physician discretion, as long as they are not known to be neurotoxic; Note: patients ideally will begin GSH therapy prior to their first dose of this chemotherapy, but must begin GSH therapy prior to their second dose of chemotherapy * Ability to sign informed consent and understand the nature of a placebo-controlled trial * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Ability to complete English language questionnaire(s) by themselves or with assistance * Life expectancy \>= 6 months * Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only, per clinician discretion * Willingness to provide blood specimens as required by the protocol * White blood cell (WBC) \>= 3400 * Absolute neutrophil count (ANC) \>= 1500 * Platelet (PLT) \>= 100,000 * Hemoglobin (HgB) \> 10.0 * Creatinine =\< 1.5 x upper limit of normal (ULN) Exclusion Criteria: * Pre-existing history of peripheral neuropathy \> grade 1 (National Cancer Institute \[NCI\] CTCAE version \[v\] 4.0) due to any cause (e.g., chemotherapy, diabetes, alcohol, toxin, or heredity) * Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient * Any of the following: * Pregnant women * Nursing women * Women of childbearing potential who are unwilling to employ adequate contraception * Prior TAXOL and/or CBDCA chemotherapy treatment (other than the current treatment regimen) * Concurrent use of any agent being used specifically to prevent or treat neuropathy, including but not limited to the following: * Gabapentin * Glutamine powder or glutamine tablets * Vitamin B6 or E

PepBank is a research reference. Talk to a doctor before you use any peptide.