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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02311907
Other study ID # NCI-2011-01965
Secondary ID NCI-2011-01965CD
Status Completed
Phase Phase 3
First received December 8, 2014
Last updated May 22, 2015
Start date December 2009
Est. completion date August 2012

Study information

Verified date May 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

PRIMARY OBJECTIVES:

I. To compare TAXOL (paclitaxel)/carboplatin (CBDCA) induced peripheral neuropathy as measured by European Organization for Research and Treatment of Cancer (EORTC)- Quality of Life (QOL)-chemotherapy induced peripheral neuropathy 20 (CIPN20) between glutathione (GSH) and placebo arms.

SECONDARY OBJECTIVES:

I. To compare the incidences of grade 2+ and grade 3+ TAXOL/CBDCA induced peripheral neuropathy measured by Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale between GSH and placebo arms.

II. To compare the time to onset of grade 2+ and grade 3+ TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms, measured by CTCAE neuropathy scale.

III. To compare the proportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms.

IV. To compare the proportion of patients stopping TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.

V. To assess the toxicity profile of GSH in this situation. VI. To evaluate whether GSH influences the anti-tumor activity of TAXOL/CBDCA. VII. To evaluate patient quality of life (QOL) measured by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) (ovarian/fallopian tube/primary peritoneal cancer patients only) and patient daily symptom questionnaires over time between GSH and placebo arms.

TERTIARY:

I. To explore the association of genetic variations in genes involved in taxane/platinum metabolism with incidence of grade 2+ TAXOL/CBDCA induced peripheral neuropathy.

II. As part of ongoing research for North Central Cancer Treatment Group (NCCTG) studies, we are banking blood products for future studies.

OUTLINE:

Patients are stratified according to baseline neuropathy (none vs grade 1), age (≤ 50 years vs > 50 years), debulked status (no gross residual disease [no clinically apparent residual lesions at the completion of primary surgery] vs optimal [largest residual lesion < 1 cm at primary surgery] vs sub-optimally debulked [residual lesion > 1 cm] or not operated upon), concurrent use of bevacizumab (yes vs no), paclitaxel planned dose (weekly vs every 3 weeks), and diabetes requiring insulin or oral hypoglycemic medications (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Ideally, patients begin receiving glutathione before their first dose of chemotherapy, but must begin glutathione before their second dose of chemotherapy.

ARM I: Patients receive glutathione intravenously (IV) over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm I.

NOTE: *Alternatively, patients may receive paclitaxel IV over 1 hour and glutathione/placebo IV over 15 minutes weekly and carboplatin every 21 days for 12 weeks.

Blood samples are collected periodically for pharmacogenomic and other biomarker analyses. Patients complete questionnaires periodically, including quality-of-life assessments.

After completion of study treatment, patients are followed up every 3 months for 1 year.


Other known NCT identifiers
  • NCT00979082

Recruitment information / eligibility

Status Completed
Enrollment 282
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Chemotherapeutic Agent Toxicity
  • Fallopian Tube Neoplasms
  • Neuropathy
  • Neurotoxicity Syndrome
  • Neurotoxicity Syndromes
  • Ovarian Neoplasms
  • Pain
  • Peripheral Nervous System Diseases
  • Peritoneal Neoplasms
  • 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

Intervention

Drug:
Carboplatin
Given IV
Glutathione
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Paclitaxel
Given IV
Other:
Placebo
Given IV
Quality-of-Life Assessment
Ancillary studies

Locations

Country Name City State
United States Abington Memorial Hospital Abington Pennsylvania
United States Pali Momi Medical Center Aiea Hawaii
United States Akron General Medical Center Akron Ohio
United States Summa Akron City Hospital/Cooper Cancer Center Akron Ohio
United States Phoebe Putney Memorial Hospital Albany Georgia
United States Medini, Eitan MD (UIA Investigator) Alexandria Minnesota
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States AnMed Health Cancer Center Anderson South Carolina
United States Michigan Cancer Research Consortium CCOP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Randolph Hospital Asheboro North Carolina
United States Atlanta Regional CCOP Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Saint Joseph's Hospital of Atlanta Atlanta Georgia
United States Georgia Regents University Medical Center Augusta Georgia
United States Harold Alfond Center for Cancer Care Augusta Maine
United States The Medical Center of Aurora Aurora Colorado
United States Well Star Cobb Hospital Austell Georgia
United States Eastern Maine Medical Center Bangor Maine
United States Summa Barberton Hospital Barberton Ohio
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States Saint Francis Hospital and Health Centers Beech Grove Indiana
United States Mary Rutan Hospital Bellefontaine Ohio
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States Hematology Oncology Associates-Quad Cities Bettendorf Iowa
United States Billings Clinic Cancer Center Billings Montana
United States Frontier Cancer Center and Blood Institute-Billings Billings Montana
United States Montana Cancer Consortium CCOP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Boulder Community Hospital Boulder Colorado
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Bozeman Deaconess Hospital Bozeman Montana
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Graham Hospital Association Canton Illinois
United States Illinois CancerCare-Canton Canton Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Memorial Hospital Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States Cedar Rapids Oncology Association Cedar Rapids Iowa
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Roper Hospital Charleston South Carolina
United States Resurrection Healthcare Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Columbus CCOP Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States John B Amos Cancer Center Columbus Georgia
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Ochsner Health Center-Covington Covington Louisiana
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton CCOP Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Samaritan North Health Center Dayton Ohio
United States Halifax Health Medical Center-Centers for Oncology Daytona Beach Florida
United States Oakwood Hospital and Medical Center Dearborn Michigan
United States Decatur Memorial Hospital Decatur Illinois
United States Dekalb Medical Center Decatur Georgia
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Cancer Research Program CCOP Denver Colorado
United States Exempla Saint Joseph Hospital Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa Oncology Research Association CCOP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Saint John Hospital and Medical Center Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Wentworth-Douglass Hospital Dover New Hampshire
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Greenville Health System Cancer Institute-Easley Easley South Carolina
United States The Memorial Hospital at Easton Easton Maryland
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Fairview-Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Northbay Cancer Center Fairfield California
United States Saint Francis Hospital Federal Way Washington
United States Blanchard Valley Hospital Findlay Ohio
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Front Range Cancer Specialists Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Hematology Oncology Associates of Fredericksburg Inc Fredericksburg Virginia
United States Cancer Care Associates of Fresno Medical Group Inc Fresno California
United States Unity Hospital Fridley Minnesota
United States Northeast Georgia Medical Center Gainesville Georgia
United States Illinois CancerCare Galesburg Galesburg Illinois
United States Glens Falls Hospital Glens Falls New York
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Big Sky Oncology Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Green Bay Wisconsin
United States Cone Health Cancer Center Greensboro North Carolina
United States Greenville Health System Cancer Institute-Butternut Greenville South Carolina
United States Greenville Health System Cancer Institute-Eastside Greenville South Carolina
United States Greenville Health System Cancer Institute-Faris Greenville South Carolina
United States Greenville Memorial Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Greenwich Hospital Greenwich Connecticut
United States Self Regional Healthcare Greenwood South Carolina
United States Cancer Centers of the Carolinas-Greer Medical Oncology Greer South Carolina
United States Saint Francis Hospital and Medical Center Hartford Connecticut
United States Ingalls Memorial Hospital Harvey Illinois
United States Illinois CancerCare-Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Northern Montana Hospital Havre Montana
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Oncare Hawaii Inc-Kuakini Honolulu Hawaii
United States Oncare Hawaii Inc-POB II Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States Mayo Clinic in Florida Jacksonville Florida
United States Castle Medical Center Kailua Hawaii
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Joseph Health Center Kansas City Missouri
United States Saint Luke's Cancer Institute Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee
United States Kinston Medical Specialists PA Kinston North Carolina
United States EvergreenHealth Medical Center Kirkland Washington
United States University of Tennessee - Knoxville Knoxville Tennessee
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Adventist La Grange Memorial Hospital La Grange Illinois
United States IU Health La Porte Hospital La Porte Indiana
United States IU Health Arnett Cancer Care Lafayette Indiana
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Gwinnett Medical Center Lawrenceville Georgia
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Liberty Hospital Liberty Missouri
United States Liberty Radiation Oncology Center Liberty Missouri
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Saint Rita's Medical Center Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Saint Mary Mercy Hospital Livonia Michigan
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Doctors Carrol, Sheth, Raghavan Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States Mcdonough District Hospital Macomb Illinois
United States Dean Hematology and Oncology Clinic Madison Wisconsin
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Mayo Clinic Health Systems-Mankato Mankato Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Wellstar Kennestone Hospital Marietta Georgia
United States Bay Area Medical Center Marinette Wisconsin
United States Marshfield Clinic Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Columbia Saint Mary's Hospital - Ozaukee Mequon Wisconsin
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Columbia Saint Mary's Water Tower Medical Commons Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Minneapolis Veterans Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Trinity Cancer Care Center Minot North Dakota
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Providence Hospital Mobile Alabama
United States Garneau, Stewart C MD (UIA Investigator) Moline Illinois
United States Porubcin, Michael MD (UIA Investigator) Moline Illinois
United States Sharis, Christine M MD (UIA Investigator) Moline Illinois
United States Spector, David MD (UIA Investigator) Moline Illinois
United States Stoffel, Thomas J MD (UIA Investigator) Moline Illinois
United States Trinity Medical Center Moline Illinois
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Louisiana State University Sciences Center- Monroe Monroe Louisiana
United States McLaren-Macomb Mount Clemens Michigan
United States Knox Community Hospital Mount Vernon Ohio
United States Saint Joseph Hospital Nashua New Hampshire
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas - Newton Newton Kansas
United States Michiana Hematology Oncology PC-Niles Niles Michigan
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Illinois CancerCare-Community Cancer Center Normal Illinois
United States Southwest VA Regional Cancer Center Norton Virginia
United States Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin
United States Providence - Saint Peter Hospital Olympia Washington
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Missouri Valley Cancer Consortium Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Ottumwa Regional Health Center Ottumwa Iowa
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States Feather River Cancer Center Paradise California
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Illinois CancerCare-Pekin Pekin Illinois
United States Pekin Cancer Treatment Center Pekin Illinois
United States Pekin Hospital Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois Oncology Research Association CCOP Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States Phoenixville Hospital Phoenixville Pennsylvania
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Saint Joseph Mercy Port Huron Port Huron Michigan
United States Kansas City CCOP Prairie Village Kansas
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Annie Penn Memorial Hospital Reidsville North Carolina
United States Valley Medical Center Renton Washington
United States Marshfield Clinic at James Beck Cancer Center Rhinelander Wisconsin
United States Marshfield Clinic-Rice Lake Center Rice Lake Wisconsin
United States Reid Hospital and Health Care Services Richmond Indiana
United States Southern Regional Medical Center Riverdale Georgia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic Rochester Minnesota
United States Cancer Trials Support Unit Rockville Maryland
United States Harbin Clinic Medical Oncology and Clinical Research Rome Georgia
United States Sutter Roseville Medical Center Roseville California
United States Sutter General Hospital Sacramento California
United States Saint Mary's of Michigan Saginaw Michigan
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Cloud Hospital Saint Cloud Minnesota
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Metro-Minnesota NCI Community Oncology Research Program Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas - Salina Salina Kansas
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Pacific Medical Center-First Hill Seattle Washington
United States Virginia Mason CCOP Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Saint Nicholas Hospital Sheboygan Wisconsin
United States Welch Cancer Center Sheridan Wyoming
United States Highland Clinic Shreveport Louisiana
United States Louisiana State University Health Sciences Center Shreveport Shreveport Louisiana
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Hematology Oncology Associates Sioux City Iowa
United States Medical X-Ray Center Sioux Falls South Dakota
United States Sanford Cancer Center-Oncology Clinic Sioux Falls South Dakota
United States Sanford NCI Community Oncology Research Program of the North Central Plains Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Robert Wood Johnson University Hospital Somerset Somerville New Jersey
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium CCOP South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States Providence Hospital Southfield Michigan
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Illinois CancerCare-Spring Valley Spring Valley Illinois
United States Saint Margaret's Hospital Spring Valley Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield Missouri
United States Springfield Regional Medical Center Springfield Ohio
United States Lakeland Hospital St. Joseph Michigan
United States Geisinger Medical Group State College Pennsylvania
United States Staten Island University Hospital Staten Island New York
United States Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States MultiCare Allenmore Hospital Tacoma Washington
United States Multicare Health System Tacoma Washington
United States Northwest CCOP Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States North Suburban Medical Center Thornton Colorado
United States Upper Valley Medical Center Troy Ohio
United States Carle Cancer Center Urbana Illinois
United States Ridgeview Medical Center Waconia Minnesota
United States Maui Memorial Medical Center Wailuku Hawaii
United States Pacific Cancer Institute of Maui Wailuku Hawaii
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Chester County Hospital West Chester Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Michiana Hematology Oncology-PC Westville Westville Indiana
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Main Office Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Via Christi Regional Medical Center Wichita Kansas
United States Wichita CCOP Wichita Kansas
United States Geisinger Wyoming Valley Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Clinton Memorial Hospital Wilmington Ohio
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology and Hematology PA-Woodbury Woodbury Minnesota
United States Wright-Patterson Medical Center Wright-Patterson Afb Ohio
United States Greene Memorial Hospital Xenia Ohio
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Genesis HealthCare System Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Paclitaxel/carboplatin (PC) induced peripheral neuropathy as assessed by EORTC QLQ-CIPN20 The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Generalized linear models (repeated measures analysis of variance [ANOVA] if data are complete) will be used to compare the CIPN between GSH and placebo arms. Up to 6 courses of therapy No
Secondary Antitumor activity of PC as defined by recurrence-free (for patients without clinical evidence of disease) or progression-free (for patients with clinical evidence of disease) survival A log-rank test and a Kaplan-Meier curve will be used to compare the recurrence free survival between GSH and placebo arms. Up to 1 year No
Secondary Association between genetic variations and grade 2+ PCI PN Logistic regression models will be used to evaluate the association of genetic variations (i.e. SNPs) with the incidence of grade 2+ neuropathy. Up to 1 year No
Secondary Change in patient reported quality of life as assessed by FACT-O and patient daily-symptom questionnaires over time Two-sample t-tests and Wilcoxon rank-sum tests will be applied to compare changes of neuropathy as measured by patient symptom log and quality of life as measured by FACT-O from baseline to the end of TAXOL/CBDCA. Baseline to 1 year No
Secondary Paclitaxel acute pain syndrome incidence and severity between GSH and placebo arms Descriptive statistics and graphical procedure will be used to describe TAXOL/CBDCA acute pain syndrome incidence/severity between GSH and placebo arms. Up to 1 year No
Secondary Percentage of patients discontinuing PC chemotherapy secondary to PN A chi-square test or Fisher's exact test will be used to compare the proportion of patients stopping TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms. Up to 1 year No
Secondary Percentage of patients undergoing dose reductions secondary to PCI PN A chi-square test or Fisher's exact test will be used to compare the proportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms. Up to 1 year No
Secondary Percentage of patients with grade 2+ and grade 3+ paclitaxel/carboplatin-induced (PCI) peripheral neuropathy (PN) according to the CTCAE neuropathy scale A chi-square test or Fisher's exact test will be used to compare the 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. Up to 1 year No
Secondary Times to onset of CTCAE grade 2+ and grade 3+ PN Kaplan-Meier curve and log-rank test will be used to compare time to grade 2+ and grade 3+ CIPN between GSH and placebo arms. Up to 1 year No
Secondary Toxicity profile of glutathione as assessed by CTCAE v4.0 Descriptive statistics (frequency and percentage) will be used to describe the toxicity profile of GSH. A Wilcoxon rank-sum test or Fisher's exact test will be applied for comparison of most frequent toxicities between GSH and placebo arms when appropriate. Up to 1 year after completion of treatment Yes
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