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

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT02311907
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 195
• Locations: 390
• Arms: 2
• Duration (Months): 32
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Carboplatin; Drug: Glutathione; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Placebo; Other: Quality-of-Life Assessment	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. 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:

1. 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.

2. 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.

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

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

5. 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:

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

2. 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), 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), and cancer type (ovarian/fallopian tube/primary peritoneal cancers vs lung cancer vs other). Patients are randomized to 1 of 2 treatment arms. Patients are grouped based on, Planned paclitaxel dose cycle length (Weekly vs. every 3 weeks vs. every 4 weeks). The stratification factors listed include demographic, prognostic factors and medication that can potentially impact the primary or secondary outcomes, so they need to be distributed evenly among the two arms. The 18 level combinations involved in these four stratification factors are within the maximum recommended of one half of the group sample size for the study.

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 1 or 3 hours depending on planned dose cycle length and carboplatin IV over 30 minutes.

ARM II: 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.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 195 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Use of Glutathione (GSH) for Prevention of Paclitaxel/Carboplatin (TAXOL/CBDCA) Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind Placebo Controlled Study
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Carboplatin; Given IV, over 30 minutes per planned chemotherapy regimen; Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplat Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo ; Drug: Glutathione; Given IV, over 15 minutes, immediately before chemotherapy administration; Other Names: Glutham GSH Reduced Glutathione ; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Paclitaxel; Given IV, over 1 or 3 hours, per planned chemotherapy regimen; Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment
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.	Drug: Carboplatin; Given IV, over 30 minutes per planned chemotherapy regimen; Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplat Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo ; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Paclitaxel; Given IV, over 1 or 3 hours, per planned chemotherapy regimen; Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat ; Other: Placebo; Given IV; Other Names: placebo therapy PLCB sham therapy ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment

Outcome Measures

Primary Outcome Measures

1. 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)). [Every 28 day cycle, up to 6 cycles.]

   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 Outcome Measures

1. Recurrence-free Survival (for Patients Without Clinical Evidence of Disease) [Up to 1 year]

   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).

2. 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. [Baseline to 1 year]

   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)

3. Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms [Up to 1 year]

   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.'

4. Percentage of Patients Delaying PC Chemotherapy Secondary to PN [Up to 1 year]

   Patients delaying TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.

5. Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN [Up to 1 year]

   Proportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms.

6. 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 [Up to 1 year]

   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).

7. Times to Onset of CTCAE Grade 2+ PN [Up to 1 year]

   Compare time to grade 2+ CIPN between GSH and placebo arms.

8. Times to Onset of CTCAE Grade 3+ PN [Up to 5 years from registration]

   Time to grade 3+ CIPN between GSH and placebo arms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Hospital	Mobile	Alabama	United States	36608
2	Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
3	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
4	Northbay Cancer Center	Fairfield	California	United States	94533
5	Cancer Care Associates of Fresno Medical Group Inc	Fresno	California	United States	93720
6	Saint Joseph Hospital - Orange	Orange	California	United States	92868
7	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
8	Feather River Cancer Center	Paradise	California	United States	95969
9	Sutter Roseville Medical Center	Roseville	California	United States	95661
10	Sutter General Hospital	Sacramento	California	United States	95816
11	The Medical Center of Aurora	Aurora	Colorado	United States	80012
12	Boulder Community Hospital	Boulder	Colorado	United States	80301
13	Penrose-Saint Francis Healthcare	Colorado Springs	Colorado	United States	80907
14	Porter Adventist Hospital	Denver	Colorado	United States	80210
15	Exempla Saint Joseph Hospital	Denver	Colorado	United States	80218
16	Presbyterian - Saint Lukes Medical Center - Health One	Denver	Colorado	United States	80218
17	Rose Medical Center	Denver	Colorado	United States	80220
18	Colorado Cancer Research Program CCOP	Denver	Colorado	United States	80224-2522
19	Swedish Medical Center	Englewood	Colorado	United States	80113
20	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
21	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80528
22	Saint Mary's Hospital and Regional Medical Center	Grand Junction	Colorado	United States	81502
23	North Colorado Medical Center	Greeley	Colorado	United States	80631
24	Saint Anthony Hospital	Lakewood	Colorado	United States	80228
25	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
26	Longmont United Hospital	Longmont	Colorado	United States	80501
27	McKee Medical Center	Loveland	Colorado	United States	80539
28	Saint Mary Corwin Medical Center	Pueblo	Colorado	United States	81004
29	North Suburban Medical Center	Thornton	Colorado	United States	80229
30	Exempla Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
31	Greenwich Hospital	Greenwich	Connecticut	United States	06830
32	Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
33	Halifax Health Medical Center-Centers for Oncology	Daytona Beach	Florida	United States	32114
34	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980
35	Phoebe Putney Memorial Hospital	Albany	Georgia	United States	31701
36	Piedmont Hospital	Atlanta	Georgia	United States	30309
37	Atlanta Regional CCOP	Atlanta	Georgia	United States	30342
38	Northside Hospital	Atlanta	Georgia	United States	30342
39	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342
40	Georgia Regents University Medical Center	Augusta	Georgia	United States	30912
41	Well Star Cobb Hospital	Austell	Georgia	United States	30106
42	John B Amos Cancer Center	Columbus	Georgia	United States	31904
43	Dekalb Medical Center	Decatur	Georgia	United States	30033
44	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
45	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
46	Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
47	Southern Regional Medical Center	Riverdale	Georgia	United States	30274
48	Harbin Clinic Medical Oncology and Clinical Research	Rome	Georgia	United States	30165
49	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia	United States	31405
50	Pali Momi Medical Center	Aiea	Hawaii	United States	96701
51	Oncare Hawaii Inc-POB II	Honolulu	Hawaii	United States	96813
52	Queen's Medical Center	Honolulu	Hawaii	United States	96813
53	Straub Clinic and Hospital	Honolulu	Hawaii	United States	96813
54	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
55	Oncare Hawaii Inc-Kuakini	Honolulu	Hawaii	United States	96817
56	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
57	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
58	Castle Medical Center	Kailua	Hawaii	United States	96734
59	Wilcox Memorial Hospital and Kauai Medical Clinic	Lihue	Hawaii	United States	96766
60	Maui Memorial Medical Center	Wailuku	Hawaii	United States	96793
61	Pacific Cancer Institute of Maui	Wailuku	Hawaii	United States	96793
62	Saint Joseph Medical Center	Bloomington	Illinois	United States	61701
63	Illinois CancerCare-Bloomington	Bloomington	Illinois	United States	61704
64	Graham Hospital Association	Canton	Illinois	United States	61520
65	Illinois CancerCare-Canton	Canton	Illinois	United States	61520
66	Illinois CancerCare-Carthage	Carthage	Illinois	United States	62321
67	Memorial Hospital	Carthage	Illinois	United States	62321
68	Presence Resurrection Medical Center	Chicago	Illinois	United States	60631
69	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
70	Eureka Hospital	Eureka	Illinois	United States	61530
71	Illinois CancerCare-Eureka	Eureka	Illinois	United States	61530
72	Illinois CancerCare Galesburg	Galesburg	Illinois	United States	61401
73	Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
74	Illinois CancerCare-Havana	Havana	Illinois	United States	62644
75	Mason District Hospital	Havana	Illinois	United States	62644
76	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois	United States	61443
77	Adventist La Grange Memorial Hospital	La Grange	Illinois	United States	60525
78	Illinois CancerCare-Macomb	Macomb	Illinois	United States	61455
79	Mcdonough District Hospital	Macomb	Illinois	United States	61455
80	Loyola University Medical Center	Maywood	Illinois	United States	60153
81	Garneau, Stewart C MD (UIA Investigator)	Moline	Illinois	United States	61265
82	Porubcin, Michael MD (UIA Investigator)	Moline	Illinois	United States	61265
83	Sharis, Christine M MD (UIA Investigator)	Moline	Illinois	United States	61265
84	Spector, David MD (UIA Investigator)	Moline	Illinois	United States	61265
85	Stoffel, Thomas J MD (UIA Investigator)	Moline	Illinois	United States	61265
86	Trinity Medical Center	Moline	Illinois	United States	61265
87	Holy Family Medical Center	Monmouth	Illinois	United States	61462
88	Illinois CancerCare-Monmouth	Monmouth	Illinois	United States	61462
89	Bromenn Regional Medical Center	Normal	Illinois	United States	61761
90	Community Cancer Center Foundation	Normal	Illinois	United States	61761
91	Illinois CancerCare-Community Cancer Center	Normal	Illinois	United States	61761
92	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois	United States	61350
93	Ottawa Regional Hospital and Healthcare Center	Ottawa	Illinois	United States	61350
94	Illinois CancerCare-Pekin	Pekin	Illinois	United States	61554
95	Pekin Cancer Treatment Center	Pekin	Illinois	United States	61554
96	Pekin Hospital	Pekin	Illinois	United States	61554
97	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61603
98	Proctor Hospital	Peoria	Illinois	United States	61614
99	OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC	Peoria	Illinois	United States	61615-7827
100	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
101	Illinois Oncology Research Association CCOP	Peoria	Illinois	United States	61615
102	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
103	Illinois CancerCare-Peru	Peru	Illinois	United States	61354
104	Illinois Valley Hospital	Peru	Illinois	United States	61354
105	Valley Radiation Oncology	Peru	Illinois	United States	61354
106	Illinois CancerCare-Princeton	Princeton	Illinois	United States	61356
107	Perry Memorial Hospital	Princeton	Illinois	United States	61356
108	Illinois CancerCare-Spring Valley	Spring Valley	Illinois	United States	61362
109	Saint Margaret's Hospital	Spring Valley	Illinois	United States	61362
110	Memorial Medical Center	Springfield	Illinois	United States	62781
111	Carle Cancer Center	Urbana	Illinois	United States	61801
112	Franciscan St. Francis Health-Beech Grove	Beech Grove	Indiana	United States	46107
113	Elkhart Clinic	Elkhart	Indiana	United States	46514-2098
114	Michiana Hematology Oncology PC-Elkhart	Elkhart	Indiana	United States	46514
115	Elkhart General Hospital	Elkhart	Indiana	United States	46515
116	Community Howard Regional Health	Kokomo	Indiana	United States	46904
117	IU Health La Porte Hospital	La Porte	Indiana	United States	46350
118	IU Health Arnett Cancer Care	Lafayette	Indiana	United States	47904
119	Franciscan Saint Anthony Health-Michigan City	Michigan City	Indiana	United States	46360
120	Michiana Hematology Oncology PC-Mishawaka	Mishawaka	Indiana	United States	46545
121	Saint Joseph Regional Medical Center-Mishawaka	Mishawaka	Indiana	United States	46545
122	Michiana Hematology Oncology PC-Plymouth	Plymouth	Indiana	United States	46563
123	Reid Hospital and Health Care Services	Richmond	Indiana	United States	47374
124	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
125	Michiana Hematology Oncology PC-South Bend	South Bend	Indiana	United States	46601
126	South Bend Clinic	South Bend	Indiana	United States	46617
127	Northern Indiana Cancer Research Consortium CCOP	South Bend	Indiana	United States	46628
128	Michiana Hematology Oncology PC-Westville	Westville	Indiana	United States	46391
129	McFarland Clinic PC-William R Bliss Cancer Center	Ames	Iowa	United States	50010
130	Constantinou, Costas L MD (UIA Investigator)	Bettendorf	Iowa	United States	52722
131	Hematology Oncology Associates-Quad Cities	Bettendorf	Iowa	United States	52722
132	Cedar Rapids Oncology Association	Cedar Rapids	Iowa	United States	52403
133	Mercy Hospital	Cedar Rapids	Iowa	United States	52403
134	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
135	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa	United States	50325
136	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
137	Iowa Oncology Research Association CCOP	Des Moines	Iowa	United States	50309
138	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
139	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
140	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
141	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
142	Ottumwa Regional Health Center	Ottumwa	Iowa	United States	52501
143	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101
144	Mercy Medical Center-Sioux City	Sioux City	Iowa	United States	51104
145	Saint Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
146	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
147	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
148	Cancer Center of Kansas - El Dorado	El Dorado	Kansas	United States	67042
149	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
150	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
151	Cancer Center of Kansas-Kingman	Kingman	Kansas	United States	67068
152	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
153	Cancer Center of Kansas-Liberal	Liberal	Kansas	United States	67901
154	Cancer Center of Kansas - McPherson	McPherson	Kansas	United States	67460
155	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
156	Menorah Medical Center	Overland Park	Kansas	United States	66209
157	Saint Luke's South Hospital	Overland Park	Kansas	United States	66213
158	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
159	Kansas City CCOP	Prairie Village	Kansas	United States	66208
160	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
161	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
162	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
163	Associates In Womens Health	Wichita	Kansas	United States	67208
164	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
165	Cancer Center of Kansas - Main Office	Wichita	Kansas	United States	67214
166	Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
167	Wichita CCOP	Wichita	Kansas	United States	67214
168	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
169	Doctors Carrol, Sheth, Raghavan	Louisville	Kentucky	United States	40215
170	Ochsner Health Center-Summa	Baton Rouge	Louisiana	United States	70809
171	Ochsner Health Center-Covington	Covington	Louisiana	United States	70433
172	Louisiana State University Sciences Center- Monroe	Monroe	Louisiana	United States	71202
173	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
174	Louisiana State University Health Sciences Center Shreveport	Shreveport	Louisiana	United States	71103
175	Highland Clinic	Shreveport	Louisiana	United States	71105
176	Harold Alfond Center for Cancer Care	Augusta	Maine	United States	04330
177	Eastern Maine Medical Center	Bangor	Maine	United States	04401
178	The Memorial Hospital at Easton	Easton	Maryland	United States	21601
179	Cancer Trials Support Unit	Rockville	Maryland	United States	20850-2062
180	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
181	Michigan Cancer Research Consortium CCOP	Ann Arbor	Michigan	United States	48106
182	Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48124
183	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
184	Green Bay Oncology - Escanaba	Escanaba	Michigan	United States	49431
185	Hurley Medical Center	Flint	Michigan	United States	48502
186	Genesys Regional Medical Center-West Flint Campus	Flint	Michigan	United States	48532
187	Green Bay Oncology - Iron Mountain	Iron Mountain	Michigan	United States	49801
188	Allegiance Health	Jackson	Michigan	United States	49201
189	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
190	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
191	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
192	Sparrow Hospital	Lansing	Michigan	United States	48912
193	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
194	McLaren-Macomb	Mount Clemens	Michigan	United States	48043
195	Michiana Hematology Oncology PC-Niles	Niles	Michigan	United States	49120
196	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
197	Saint Joseph Mercy Port Huron	Port Huron	Michigan	United States	48060
198	Saint Mary's of Michigan	Saginaw	Michigan	United States	48601
199	Marie Yeager Cancer Center	Saint Joseph	Michigan	United States	49085
200	Providence Hospital-Southfield Cancer Center	Southfield	Michigan	United States	48075
201	Lakeland Hospital	St. Joseph	Michigan	United States	49085
202	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
203	Medini, Eitan MD (UIA Investigator)	Alexandria	Minnesota	United States	56308
204	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
205	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
206	Essentia Health Cancer Center	Duluth	Minnesota	United States	55805
207	Essentia Health Saint Mary's Medical Center	Duluth	Minnesota	United States	55805
208	Miller-Dwan Hospital	Duluth	Minnesota	United States	55805
209	Fairview-Southdale Hospital	Edina	Minnesota	United States	55435
210	Unity Hospital	Fridley	Minnesota	United States	55432
211	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
212	Mayo Clinic Health Systems-Mankato	Mankato	Minnesota	United States	56001
213	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota	United States	55109
214	Saint John's Hospital - Healtheast	Maplewood	Minnesota	United States	55109
215	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
216	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
217	Minneapolis Veterans Medical Center	Minneapolis	Minnesota	United States	55417
218	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
219	Mayo Clinic	Rochester	Minnesota	United States	55905
220	Coborn Cancer Center at Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
221	Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
222	Metro-Minnesota NCI Community Oncology Research Program	Saint Louis Park	Minnesota	United States	55416
223	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
224	Regions Hospital	Saint Paul	Minnesota	United States	55101
225	United Hospital	Saint Paul	Minnesota	United States	55102
226	Saint Francis Regional Medical Center	Shakopee	Minnesota	United States	55379
227	Lakeview Hospital	Stillwater	Minnesota	United States	55082
228	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
229	Rice Memorial Hospital	Willmar	Minnesota	United States	56201
230	Minnesota Oncology and Hematology PA-Woodbury	Woodbury	Minnesota	United States	55125
231	Saint Luke's Cancer Institute	Kansas City	Missouri	United States	64111
232	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
233	Saint Joseph Health Center	Kansas City	Missouri	United States	64114
234	North Kansas City Hospital	Kansas City	Missouri	United States	64116
235	Heartland Hematology and Oncology Associates Incorporated	Kansas City	Missouri	United States	64118
236	Research Medical Center	Kansas City	Missouri	United States	64132
237	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri	United States	64086
238	Liberty Hospital	Liberty	Missouri	United States	64068
239	Liberty Radiation Oncology Center	Liberty	Missouri	United States	64068
240	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
241	Saint Joseph Oncology Inc	Saint Joseph	Missouri	United States	64507
242	Cancer Research for the Ozarks NCORP	Springfield	Missouri	United States	65804
243	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
244	CoxHealth South Hospital	Springfield	Missouri	United States	65807
245	Montana Cancer Consortium CCOP	Billings	Montana	United States	59101
246	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
247	Saint Vincent Healthcare	Billings	Montana	United States	59101
248	Frontier Cancer Center and Blood Institute-Billings	Billings	Montana	United States	59102
249	Billings Clinic Cancer Center	Billings	Montana	United States	59107
250	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
251	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
252	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
253	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
254	Berdeaux, Donald MD (UIA Investigator)	Great Falls	Montana	United States	59405
255	Big Sky Oncology	Great Falls	Montana	United States	59405
256	Great Falls Clinic	Great Falls	Montana	United States	59405
257	Northern Montana Hospital	Havre	Montana	United States	59501
258	Saint Peter's Community Hospital	Helena	Montana	United States	59601
259	Glacier Oncology PLLC	Kalispell	Montana	United States	59901
260	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
261	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
262	Community Medical Hospital	Missoula	Montana	United States	59801
263	Montana Cancer Specialists	Missoula	Montana	United States	59802
264	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
265	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
266	Nebraska Cancer Research Center	Lincoln	Nebraska	United States	68510
267	Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
268	Alegent Health Immanuel Medical Center	Omaha	Nebraska	United States	68122
269	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
270	Creighton University Medical Center	Omaha	Nebraska	United States	68131
271	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
272	Nevada Cancer Research Foundation CCOP	Las Vegas	Nevada	United States	89106
273	Wentworth-Douglass Hospital	Dover	New Hampshire	United States	03820
274	Saint Joseph Hospital	Nashua	New Hampshire	United States	03060
275	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey	United States	08876
276	Glens Falls Hospital	Glens Falls	New York	United States	12801
277	Staten Island University Hospital	Staten Island	New York	United States	10305
278	Randolph Hospital	Asheboro	North Carolina	United States	27203
279	Wayne Memorial Hospital	Goldsboro	North Carolina	United States	27534
280	Cone Health Cancer Center	Greensboro	North Carolina	United States	27403
281	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
282	Kinston Medical Specialists PA	Kinston	North Carolina	United States	28501
283	Annie Penn Memorial Hospital	Reidsville	North Carolina	United States	27320
284	Mid Dakota Clinic	Bismarck	North Dakota	United States	58501
285	Saint Alexius Medical Center	Bismarck	North Dakota	United States	58501
286	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
287	Altru Cancer Center	Grand Forks	North Dakota	United States	58201
288	Trinity Cancer Care Center	Minot	North Dakota	United States	58701
289	Summa Akron City Hospital/Cooper Cancer Center	Akron	Ohio	United States	44304
290	Akron General Medical Center	Akron	Ohio	United States	44307
291	Summa Barberton Hospital	Barberton	Ohio	United States	44203
292	Mary Rutan Hospital	Bellefontaine	Ohio	United States	43311
293	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
294	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
295	Columbus CCOP	Columbus	Ohio	United States	43215
296	Grant Medical Center	Columbus	Ohio	United States	43215
297	Mount Carmel Health Center West	Columbus	Ohio	United States	43222
298	Doctors Hospital	Columbus	Ohio	United States	43228
299	Grandview Hospital	Dayton	Ohio	United States	45405
300	Good Samaritan Hospital - Dayton	Dayton	Ohio	United States	45406
301	Miami Valley Hospital	Dayton	Ohio	United States	45409
302	Samaritan North Health Center	Dayton	Ohio	United States	45415
303	Dayton CCOP	Dayton	Ohio	United States	45420
304	Grady Memorial Hospital	Delaware	Ohio	United States	43015
305	Blanchard Valley Hospital	Findlay	Ohio	United States	45840
306	Atrium Medical Center-Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
307	Wayne Hospital	Greenville	Ohio	United States	45331
308	Kettering Medical Center	Kettering	Ohio	United States	45429
309	Fairfield Medical Center	Lancaster	Ohio	United States	43130
310	Saint Rita's Medical Center	Lima	Ohio	United States	45801
311	Marietta Memorial Hospital	Marietta	Ohio	United States	45750
312	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
313	Licking Memorial Hospital	Newark	Ohio	United States	43055
314	Springfield Regional Medical Center	Springfield	Ohio	United States	45505
315	Upper Valley Medical Center	Troy	Ohio	United States	45373
316	Saint Ann's Hospital	Westerville	Ohio	United States	43081
317	Clinton Memorial Hospital	Wilmington	Ohio	United States	45177
318	Wright-Patterson Medical Center	Wright-Patterson Afb	Ohio	United States	45433-5529
319	Greene Memorial Hospital	Xenia	Ohio	United States	45385
320	Genesis HealthCare System	Zanesville	Ohio	United States	43701
321	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
322	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
323	Geisinger Medical Center-Cancer Center Hazleton	Hazleton	Pennsylvania	United States	18201
324	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
325	Phoenixville Hospital	Phoenixville	Pennsylvania	United States	19460
326	Guthrie Medical Group PC-Robert Packer Hospital	Sayre	Pennsylvania	United States	18840
327	Geisinger Medical Group	State College	Pennsylvania	United States	16801
328	Chester County Hospital	West Chester	Pennsylvania	United States	19380
329	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania	United States	18711
330	AnMed Health Cancer Center	Anderson	South Carolina	United States	29621
331	Roper Hospital	Charleston	South Carolina	United States	29401
332	Greenville Health System Cancer Institute-Easley	Easley	South Carolina	United States	29640
333	McLeod Regional Medical Center	Florence	South Carolina	United States	29506
334	Greenville Health System Cancer Institute-Butternut	Greenville	South Carolina	United States	29605
335	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina	United States	29605
336	Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
337	Greenville Health System Cancer Institute-Eastside	Greenville	South Carolina	United States	29615
338	Self Regional Healthcare	Greenwood	South Carolina	United States	29646
339	Cancer Centers of the Carolinas-Greer Medical Oncology	Greer	South Carolina	United States	29650
340	Greenville Health System Cancer Institute-Seneca	Seneca	South Carolina	United States	29672
341	Greenville Health System Cancer Institute-Spartanburg	Spartanburg	South Carolina	United States	29307
342	Sanford Cancer Center-Oncology Clinic	Sioux Falls	South Dakota	United States	57104
343	Sanford NCI Community Oncology Research Program of the North Central Plains	Sioux Falls	South Dakota	United States	57104
344	Medical X-Ray Center	Sioux Falls	South Dakota	United States	57105
345	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
346	Wellmont Holston Valley Hospital and Medical Center	Kingsport	Tennessee	United States	37660
347	University of Tennessee - Knoxville	Knoxville	Tennessee	United States	37920
348	Hematology Oncology Associates of Fredericksburg Inc	Fredericksburg	Virginia	United States	22408
349	Southwest VA Regional Cancer Center	Norton	Virginia	United States	24273
350	PeaceHealth Saint Joseph Medical Center	Bellingham	Washington	United States	98225
351	Providence Regional Cancer System-Centralia	Centralia	Washington	United States	98531
352	Saint Francis Hospital	Federal Way	Washington	United States	98003
353	EvergreenHealth Medical Center	Kirkland	Washington	United States	98033
354	Saint Clare Hospital	Lakewood	Washington	United States	98499
355	Providence - Saint Peter Hospital	Olympia	Washington	United States	98506-5166
356	MultiCare Good Samaritan Hospital	Puyallup	Washington	United States	98372
357	Valley Medical Center	Renton	Washington	United States	98055
358	Virginia Mason CCOP	Seattle	Washington	United States	98101
359	Virginia Mason Medical Center	Seattle	Washington	United States	98101
360	Pacific Medical Center-First Hill	Seattle	Washington	United States	98104
361	MultiCare Allenmore Hospital	Tacoma	Washington	United States	98405
362	Northwest CCOP	Tacoma	Washington	United States	98405
363	Saint Joseph Medical Center	Tacoma	Washington	United States	98405
364	Multicare Health System	Tacoma	Washington	United States	98415
365	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington	United States	98902
366	Edwards Comprehensive Cancer Center	Huntington	West Virginia	United States	25701
367	Marshfield Clinic-Chippewa Center	Chippewa Falls	Wisconsin	United States	54729
368	Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin	United States	54701
369	Green Bay Oncology at Saint Vincent Hospital	Green Bay	Wisconsin	United States	54301-3526
370	Saint Vincent Hospital	Green Bay	Wisconsin	United States	54301
371	Green Bay Oncology Limited at Saint Mary's Hospital	Green Bay	Wisconsin	United States	54303
372	Saint Mary's Hospital	Green Bay	Wisconsin	United States	54303
373	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
374	Dean Hematology and Oncology Clinic	Madison	Wisconsin	United States	53717
375	Holy Family Memorial Hospital	Manitowoc	Wisconsin	United States	54221
376	Bay Area Medical Center	Marinette	Wisconsin	United States	54143
377	Marshfield Clinic	Marshfield	Wisconsin	United States	54449
378	Columbia Saint Mary's Hospital - Ozaukee	Mequon	Wisconsin	United States	53097
379	Columbia Saint Mary's Water Tower Medical Commons	Milwaukee	Wisconsin	United States	53211
380	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
381	Green Bay Oncology - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
382	Marshfield Clinic at James Beck Cancer Center	Rhinelander	Wisconsin	United States	54501
383	Marshfield Clinic-Rice Lake Center	Rice Lake	Wisconsin	United States	54868
384	Saint Nicholas Hospital	Sheboygan	Wisconsin	United States	53081
385	Marshfield Clinic Cancer Care at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
386	Green Bay Oncology - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
387	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
388	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
389	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
390	Welch Cancer Center	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Charles Loprinzi, Alliance for Clinical Trials in Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT02311907
• Other Study ID Numbers: N08CA; NCI-2011-01965; CDR0000654097; U10CA037404; NCT00979082
• First Posted: Dec 9, 2014
• Last Update Posted: Feb 23, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes; Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Recruitment Details	Total of 195 patients were enrolled, 185 started the treatment (8 cancels, 1 ineligible and 1 excluded due to switching regimens).

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Period Title: Overall Study
STARTED	94	91
COMPLETED	94	91
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)	Total
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.	Total of all reporting groups
Overall Participants	94	91	185
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	63	63	63
Gender (Count of Participants)
Female	74 78.7%	76 83.5%	150 81.1%
Male	20 21.3%	15 16.5%	35 18.9%
Region of Enrollment (participants) [Number]
United States	94 100%	91 100%	185 100%

Outcome Measures

1. Primary Outcome

Title	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)).
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.
Time Frame	Every 28 day cycle, up to 6 cycles.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Measure Participants	94	91
Least Squares Mean (Standard Error) [Units on a scale 1-100]	83.7 (0.89)	82.1 (0.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A (Glutathione, Carboplatin), B (Placebo, Paclitaxel)
	Comments	Generalized linear models (repeated measures analysis of variance [ANOVA]) will be used to compare the CIPN between GSH and placebo arms.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)
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).
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Patients without clinical evidence of disease.

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Measure Participants	45	40
Median (95% Confidence Interval) [Median survival time in days]	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A (Glutathione, Carboplatin), B (Placebo, Paclitaxel)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments
	Method	Log Rank
	Comments

3. Secondary Outcome

Title	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.
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)
Time Frame	Baseline to 1 year

Outcome Measure Data

Analysis Population Description

FACT-O Change from Baseline to cycle 6 data available for 34 patients.

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Measure Participants	17	17
FACT-O Physical Subscale Chg from Bsl	-14.3	-8.9
FACT-O Social/Family Subscale Chg from Bsl	-4.2	0.0
FACT-O Emotional Subscale Chg from Bsl	8.3	4.2
FACT-O Functional Subscale Chg from Bsl	0.0	5.1
FACT-O Additional Concerns Subscale Chg from Bsl	-2.3	4.8
FACT-O Total Score Chg from Bsl	0.3	4.4

4. Secondary Outcome

Title	Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms
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.'
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Measure Participants	94	91
Median (Full Range) [units on a scale]	2.0	2.0

5. Secondary Outcome

Title	Percentage of Patients Delaying PC Chemotherapy Secondary to PN
Description	Patients delaying TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Measure Participants	94	91
Number [Percentage of participants]	1.1 1.2%	0 0%

6. Secondary Outcome

Title	Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN
Description	Proportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Measure Participants	94	91
Reduced TAXOL Dose : Yes	2.1 2.2%	1.1 1.2%
Reduced CARBO Dose: Yes	1.1 1.2%	0.0 0%

7. Secondary Outcome

Title	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
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).
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Measure Participants	94	91
Grade 2+ CIPN: Yes	38.3 40.7%	33.0 36.3%
Grade 3+ CIPN: Yes	5.3 5.6%	4.4 4.8%

8. Secondary Outcome

Title	Times to Onset of CTCAE Grade 2+ PN
Description	Compare time to grade 2+ CIPN between GSH and placebo arms.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Number of Participants analyzed is 93 for Arm I due to error in date entered.

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Measure Participants	93	91
Median (Standard Error) [days]	140 (18.5)	234 (26.1)

9. Secondary Outcome

Title	Times to Onset of CTCAE Grade 3+ PN
Description	Time to grade 3+ CIPN between GSH and placebo arms.
Time Frame	Up to 5 years from registration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A (Glutathione, Carboplatin)	B (Placebo, Paclitaxel)
Arm/Group Description	Patients receive glutathione 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.	Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Measure Participants	94	91
Median (95% Confidence Interval) [days]	NA	NA

Adverse Events

Arm/Group Title	A (Glutathione, Carboplatin)		B (Placebo, Paclitaxel)
Arm/Group Description	Quality-of-Life Assessment: Ancillary studies		Quality-of-Life Assessment: Ancillary studies
All Cause Mortality
	A (Glutathione, Carboplatin)		B (Placebo, Paclitaxel)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	A (Glutathione, Carboplatin)		B (Placebo, Paclitaxel)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/94 (7.4%)		1/91 (1.1%)
Blood and lymphatic system disorders
Anemia	1/94 (1.1%)	1	0/91 (0%)	0
General disorders
Pain	1/94 (1.1%)	1	0/91 (0%)	0
Infections and infestations
Lung infection	0/94 (0%)	0	1/91 (1.1%)	1
Investigations
Neutrophil count decreased	1/94 (1.1%)	1	1/91 (1.1%)	1
White blood cell decreased	0/94 (0%)	0	1/91 (1.1%)	1
Nervous system disorders
Peripheral motor neuropathy	1/94 (1.1%)	1	0/91 (0%)	0
Peripheral sensory neuropathy	1/94 (1.1%)	2	0/91 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/94 (0%)	0	1/91 (1.1%)	1
Dyspnea	0/94 (0%)	0	1/91 (1.1%)	1
Vascular disorders
Thromboembolic event	3/94 (3.2%)	3	0/91 (0%)	0
Other (Not Including Serious) Adverse Events
	A (Glutathione, Carboplatin)		B (Placebo, Paclitaxel)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	64/94 (68.1%)		62/91 (68.1%)
Blood and lymphatic system disorders
Anemia	12/94 (12.8%)	22	15/91 (16.5%)	28
Blood and lymphatic system disorders - Other, specify	0/94 (0%)	0	1/91 (1.1%)	1
Febrile neutropenia	1/94 (1.1%)	1	1/91 (1.1%)	1
Leukocytosis	1/94 (1.1%)	2	0/91 (0%)	0
Cardiac disorders
Atrial fibrillation	0/94 (0%)	0	1/91 (1.1%)	1
Heart failure	0/94 (0%)	0	1/91 (1.1%)	1
Pericardial effusion	1/94 (1.1%)	1	0/91 (0%)	0
Pericardial tamponade	0/94 (0%)	0	1/91 (1.1%)	1
Ear and labyrinth disorders
Hearing impaired	1/94 (1.1%)	2	0/91 (0%)	0
Gastrointestinal disorders
Abdominal distension	1/94 (1.1%)	1	0/91 (0%)	0
Abdominal pain	3/94 (3.2%)	3	2/91 (2.2%)	2
Colonic obstruction	1/94 (1.1%)	1	1/91 (1.1%)	1
Constipation	3/94 (3.2%)	3	4/91 (4.4%)	7
Diarrhea	0/94 (0%)	0	3/91 (3.3%)	3
Duodenal perforation	0/94 (0%)	0	1/91 (1.1%)	1
Dyspepsia	2/94 (2.1%)	4	0/91 (0%)	0
Gastrointestinal disorders - Other, specify	1/94 (1.1%)	1	0/91 (0%)	0
Lower gastrointestinal hemorrhage	0/94 (0%)	0	1/91 (1.1%)	1
Nausea	3/94 (3.2%)	3	4/91 (4.4%)	4
Rectal hemorrhage	1/94 (1.1%)	1	1/91 (1.1%)	1
Rectal ulcer	0/94 (0%)	0	1/91 (1.1%)	1
Small intestinal obstruction	1/94 (1.1%)	1	1/91 (1.1%)	1
Upper gastrointestinal hemorrhage	0/94 (0%)	0	1/91 (1.1%)	1
Vomiting	2/94 (2.1%)	2	4/91 (4.4%)	4
General disorders
Death NOS	3/94 (3.2%)	3	2/91 (2.2%)	3
Edema limbs	2/94 (2.1%)	3	0/91 (0%)	0
Edema trunk	1/94 (1.1%)	2	0/91 (0%)	0
Fatigue	10/94 (10.6%)	18	9/91 (9.9%)	11
Infusion related reaction	1/94 (1.1%)	1	0/91 (0%)	0
Pain	1/94 (1.1%)	1	2/91 (2.2%)	2
Immune system disorders
Anaphylaxis	2/94 (2.1%)	2	0/91 (0%)	0
Infections and infestations
Anorectal infection	1/94 (1.1%)	1	0/91 (0%)	0
Bladder infection	1/94 (1.1%)	3	0/91 (0%)	0
Enterocolitis infectious	1/94 (1.1%)	1	0/91 (0%)	0
Infections and infestations - Other, specify	0/94 (0%)	0	1/91 (1.1%)	1
Lung infection	2/94 (2.1%)	2	0/91 (0%)	0
Nail infection	1/94 (1.1%)	1	0/91 (0%)	0
Papulopustular rash	1/94 (1.1%)	1	0/91 (0%)	0
Paronychia	1/94 (1.1%)	1	0/91 (0%)	0
Sepsis	1/94 (1.1%)	1	1/91 (1.1%)	1
Skin infection	1/94 (1.1%)	3	0/91 (0%)	0
Soft tissue infection	1/94 (1.1%)	1	0/91 (0%)	0
Tooth infection	1/94 (1.1%)	1	0/91 (0%)	0
Upper respiratory infection	0/94 (0%)	0	2/91 (2.2%)	3
Urinary tract infection	0/94 (0%)	0	3/91 (3.3%)	3
Injury, poisoning and procedural complications
Fracture	0/94 (0%)	0	1/91 (1.1%)	1
Intraoperative ocular injury	0/94 (0%)	0	1/91 (1.1%)	1
Investigations
Alanine aminotransferase increased	1/94 (1.1%)	1	0/91 (0%)	0
Aspartate aminotransferase increased	1/94 (1.1%)	1	1/91 (1.1%)	1
Hemoglobin increased	1/94 (1.1%)	1	1/91 (1.1%)	1
INR increased	2/94 (2.1%)	2	0/91 (0%)	0
Lymphocyte count decreased	4/94 (4.3%)	5	7/91 (7.7%)	15
Lymphocyte count increased	0/94 (0%)	0	1/91 (1.1%)	1
Neutrophil count decreased	22/94 (23.4%)	44	17/91 (18.7%)	31
Platelet count decreased	6/94 (6.4%)	8	10/91 (11%)	18
Weight gain	1/94 (1.1%)	2	0/91 (0%)	0
White blood cell decreased	9/94 (9.6%)	13	9/91 (9.9%)	14
Metabolism and nutrition disorders
Acidosis	0/94 (0%)	0	1/91 (1.1%)	1
Anorexia	6/94 (6.4%)	7	3/91 (3.3%)	3
Dehydration	1/94 (1.1%)	1	3/91 (3.3%)	3
Hyperglycemia	2/94 (2.1%)	6	5/91 (5.5%)	8
Hypoalbuminemia	1/94 (1.1%)	1	0/91 (0%)	0
Hypokalemia	1/94 (1.1%)	1	1/91 (1.1%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	2/94 (2.1%)	2	1/91 (1.1%)	1
Back pain	2/94 (2.1%)	2	2/91 (2.2%)	2
Bone pain	1/94 (1.1%)	1	0/91 (0%)	0
Generalized muscle weakness	1/94 (1.1%)	1	2/91 (2.2%)	2
Muscle weakness lower limb	0/94 (0%)	0	1/91 (1.1%)	1
Myalgia	1/94 (1.1%)	1	2/91 (2.2%)	2
Pain in extremity	2/94 (2.1%)	2	4/91 (4.4%)	5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0/94 (0%)	0	2/91 (2.2%)	2
Tumor pain	0/94 (0%)	0	1/91 (1.1%)	1
Nervous system disorders
Dizziness	1/94 (1.1%)	1	0/91 (0%)	0
Dysgeusia	0/94 (0%)	0	1/91 (1.1%)	1
Headache	0/94 (0%)	0	1/91 (1.1%)	1
Hydrocephalus	0/94 (0%)	0	1/91 (1.1%)	1
Intracranial hemorrhage	0/94 (0%)	0	1/91 (1.1%)	1
Peripheral motor neuropathy	1/94 (1.1%)	2	1/91 (1.1%)	1
Peripheral sensory neuropathy	12/94 (12.8%)	20	7/91 (7.7%)	12
Syncope	0/94 (0%)	0	2/91 (2.2%)	2
Psychiatric disorders
Anxiety	1/94 (1.1%)	1	0/91 (0%)	0
Depression	1/94 (1.1%)	1	0/91 (0%)	0
Renal and urinary disorders
Urinary tract obstruction	0/94 (0%)	0	2/91 (2.2%)	3
Respiratory, thoracic and mediastinal disorders
Aspiration	2/94 (2.1%)	2	0/91 (0%)	0
Cough	1/94 (1.1%)	2	0/91 (0%)	0
Dyspnea	3/94 (3.2%)	4	3/91 (3.3%)	3
Hypoxia	1/94 (1.1%)	1	0/91 (0%)	0
Pleural effusion	1/94 (1.1%)	1	2/91 (2.2%)	2
Pneumonitis	0/94 (0%)	0	2/91 (2.2%)	2
Pneumothorax	0/94 (0%)	0	1/91 (1.1%)	1
Respiratory failure	1/94 (1.1%)	1	1/91 (1.1%)	1
Wheezing	1/94 (1.1%)	2	0/91 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	7/94 (7.4%)	11	4/91 (4.4%)	7
Dry skin	1/94 (1.1%)	1	0/91 (0%)	0
Hyperhidrosis	0/94 (0%)	0	1/91 (1.1%)	2
Pruritus	1/94 (1.1%)	1	1/91 (1.1%)	1
Rash maculo-papular	1/94 (1.1%)	1	0/91 (0%)	0
Urticaria	1/94 (1.1%)	1	0/91 (0%)	0
Vascular disorders
Hot flashes	1/94 (1.1%)	1	0/91 (0%)	0
Hypertension	1/94 (1.1%)	2	6/91 (6.6%)	7
Hypotension	0/94 (0%)	0	1/91 (1.1%)	2
Thromboembolic event	5/94 (5.3%)	6	1/91 (1.1%)	1

Limitations/Caveats

[Not Specified]

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.