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

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ClinicalTrials.gov Identifier: NCT02311907
Recruitment Status : Completed
First Posted : December 9, 2014
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions Chemotherapeutic Agent Toxicity
Neuropathy
Neurotoxicity Syndrome
Pain
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Primary Peritoneal Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Cancer
Stage IIIB Primary Peritoneal Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IIIC Primary Peritoneal Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Cancer
Stage IV Primary Peritoneal Cancer
Interventions Drug: Carboplatin
Drug: Glutathione
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Placebo
Other: Quality-of-Life Assessment
Enrollment 195
Recruitment Details Total of 195 patients were enrolled, 185 started the treatment (8 cancels, 1 ineligible and 1 excluded due to switching regimens).
Pre-assignment Details  
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Hide 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
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel) Total
Hide 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 Number of Baseline Participants 94 91 185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 94 participants 91 participants 185 participants
63
(37 to 85)
63
(28 to 84)
63
(28 to 85)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 91 participants 185 participants
Female
74
  78.7%
76
  83.5%
150
  81.1%
Male
20
  21.3%
15
  16.5%
35
  18.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 94 participants 91 participants 185 participants
94 91 185
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)).
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Hide 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.
Overall Number of Participants Analyzed 94 91
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale 1-100
83.7  (0.89) 82.1  (0.93)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients without clinical evidence of disease.
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Hide 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.
Overall Number of Participants Analyzed 45 40
Median (95% Confidence Interval)
Unit of Measure: Median survival time in days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A (Glutathione, Carboplatin), B (Placebo, Paclitaxel)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
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.
Hide 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
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Hide 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)
Hide 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.
Overall Number of Participants Analyzed 17 17
Median (Full Range)
Unit of Measure: units on a scale
FACT-O Physical Subscale Chg from Bsl
-14.3
(-57.1 to 57.1)
-8.9
(-75.0 to 14.3)
FACT-O Social/Family Subscale Chg from Bsl
-4.2
(-28.6 to 4.2)
0.0
(-100.0 to 21.4)
FACT-O Emotional Subscale Chg from Bsl
8.3
(-45.8 to 37.5)
4.2
(-20.8 to 45.8)
FACT-O Functional Subscale Chg from Bsl
0.0
(-32.1 to 21.4)
5.1
(-96.4 to 42.9)
FACT-O Additional Concerns Subscale Chg from Bsl
-2.3
(-22.7 to 20.5)
4.8
(-29.5 to 19.8)
FACT-O Total Score Chg from Bsl
0.3
(-27.6 to 13.3)
4.4
(-39.5 to 16.1)
4.Secondary Outcome
Title Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Hide 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.
Overall Number of Participants Analyzed 94 91
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 10)
2.0
(0 to 10)
5.Secondary Outcome
Title Percentage of Patients Delaying PC Chemotherapy Secondary to PN
Hide Description Patients delaying TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.
Time Frame Up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Hide 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.
Overall Number of Participants Analyzed 94 91
Measure Type: Number
Unit of Measure: Percentage of participants
1.1 0
6.Secondary Outcome
Title Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Hide 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.
Overall Number of Participants Analyzed 94 91
Measure Type: Number
Unit of Measure: percentage of participants
Reduced TAXOL Dose : Yes 2.1 1.1
Reduced CARBO Dose: Yes 1.1 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Hide 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.
Overall Number of Participants Analyzed 94 91
Measure Type: Number
Unit of Measure: percentage of participants
Grade 2+ CIPN: Yes 38.3 33.0
Grade 3+ CIPN: Yes 5.3 4.4
8.Secondary Outcome
Title Times to Onset of CTCAE Grade 2+ PN
Hide Description Compare time to grade 2+ CIPN between GSH and placebo arms.
Time Frame Up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 93 91
Median (Standard Error)
Unit of Measure: days
140  (18.5) 234  (26.1)
9.Secondary Outcome
Title Times to Onset of CTCAE Grade 3+ PN
Hide Description Time to grade 3+ CIPN between GSH and placebo arms.
Time Frame Up to 5 years from registration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Hide 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.
Overall Number of Participants Analyzed 94 91
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with events
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/94 (7.45%)      1/91 (1.10%)    
Blood and lymphatic system disorders     
Anemia  1  1/94 (1.06%)  1 0/91 (0.00%)  0
General disorders     
Pain  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Infections and infestations     
Lung infection  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Investigations     
Neutrophil count decreased  1  1/94 (1.06%)  1 1/91 (1.10%)  1
White blood cell decreased  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Nervous system disorders     
Peripheral motor neuropathy  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Peripheral sensory neuropathy  1  1/94 (1.06%)  2 0/91 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Dyspnea  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Vascular disorders     
Thromboembolic event  1  3/94 (3.19%)  3 0/91 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A (Glutathione, Carboplatin) B (Placebo, Paclitaxel)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   64/94 (68.09%)      62/91 (68.13%)    
Blood and lymphatic system disorders     
Anemia  1  12/94 (12.77%)  22 15/91 (16.48%)  28
Blood and lymphatic system disorders - Other, specify  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Febrile neutropenia  1  1/94 (1.06%)  1 1/91 (1.10%)  1
Leukocytosis  1  1/94 (1.06%)  2 0/91 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Heart failure  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Pericardial effusion  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Pericardial tamponade  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Ear and labyrinth disorders     
Hearing impaired  1  1/94 (1.06%)  2 0/91 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Abdominal pain  1  3/94 (3.19%)  3 2/91 (2.20%)  2
Colonic obstruction  1  1/94 (1.06%)  1 1/91 (1.10%)  1
Constipation  1  3/94 (3.19%)  3 4/91 (4.40%)  7
Diarrhea  1  0/94 (0.00%)  0 3/91 (3.30%)  3
Duodenal perforation  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Dyspepsia  1  2/94 (2.13%)  4 0/91 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Lower gastrointestinal hemorrhage  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Nausea  1  3/94 (3.19%)  3 4/91 (4.40%)  4
Rectal hemorrhage  1  1/94 (1.06%)  1 1/91 (1.10%)  1
Rectal ulcer  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Small intestinal obstruction  1  1/94 (1.06%)  1 1/91 (1.10%)  1
Upper gastrointestinal hemorrhage  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Vomiting  1  2/94 (2.13%)  2 4/91 (4.40%)  4
General disorders     
Death NOS  1  3/94 (3.19%)  3 2/91 (2.20%)  3
Edema limbs  1  2/94 (2.13%)  3 0/91 (0.00%)  0
Edema trunk  1  1/94 (1.06%)  2 0/91 (0.00%)  0
Fatigue  1  10/94 (10.64%)  18 9/91 (9.89%)  11
Infusion related reaction  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Pain  1  1/94 (1.06%)  1 2/91 (2.20%)  2
Immune system disorders     
Anaphylaxis  1  2/94 (2.13%)  2 0/91 (0.00%)  0
Infections and infestations     
Anorectal infection  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Bladder infection  1  1/94 (1.06%)  3 0/91 (0.00%)  0
Enterocolitis infectious  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Infections and infestations - Other, specify  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Lung infection  1  2/94 (2.13%)  2 0/91 (0.00%)  0
Nail infection  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Papulopustular rash  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Paronychia  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Sepsis  1  1/94 (1.06%)  1 1/91 (1.10%)  1
Skin infection  1  1/94 (1.06%)  3 0/91 (0.00%)  0
Soft tissue infection  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Tooth infection  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Upper respiratory infection  1  0/94 (0.00%)  0 2/91 (2.20%)  3
Urinary tract infection  1  0/94 (0.00%)  0 3/91 (3.30%)  3
Injury, poisoning and procedural complications     
Fracture  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Intraoperative ocular injury  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Investigations     
Alanine aminotransferase increased  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Aspartate aminotransferase increased  1  1/94 (1.06%)  1 1/91 (1.10%)  1
Hemoglobin increased  1  1/94 (1.06%)  1 1/91 (1.10%)  1
INR increased  1  2/94 (2.13%)  2 0/91 (0.00%)  0
Lymphocyte count decreased  1  4/94 (4.26%)  5 7/91 (7.69%)  15
Lymphocyte count increased  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Neutrophil count decreased  1  22/94 (23.40%)  44 17/91 (18.68%)  31
Platelet count decreased  1  6/94 (6.38%)  8 10/91 (10.99%)  18
Weight gain  1  1/94 (1.06%)  2 0/91 (0.00%)  0
White blood cell decreased  1  9/94 (9.57%)  13 9/91 (9.89%)  14
Metabolism and nutrition disorders     
Acidosis  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Anorexia  1  6/94 (6.38%)  7 3/91 (3.30%)  3
Dehydration  1  1/94 (1.06%)  1 3/91 (3.30%)  3
Hyperglycemia  1  2/94 (2.13%)  6 5/91 (5.49%)  8
Hypoalbuminemia  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Hypokalemia  1  1/94 (1.06%)  1 1/91 (1.10%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/94 (2.13%)  2 1/91 (1.10%)  1
Back pain  1  2/94 (2.13%)  2 2/91 (2.20%)  2
Bone pain  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Generalized muscle weakness  1  1/94 (1.06%)  1 2/91 (2.20%)  2
Muscle weakness lower limb  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Myalgia  1  1/94 (1.06%)  1 2/91 (2.20%)  2
Pain in extremity  1  2/94 (2.13%)  2 4/91 (4.40%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/94 (0.00%)  0 2/91 (2.20%)  2
Tumor pain  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Nervous system disorders     
Dizziness  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Dysgeusia  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Headache  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Hydrocephalus  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Intracranial hemorrhage  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Peripheral motor neuropathy  1  1/94 (1.06%)  2 1/91 (1.10%)  1
Peripheral sensory neuropathy  1  12/94 (12.77%)  20 7/91 (7.69%)  12
Syncope  1  0/94 (0.00%)  0 2/91 (2.20%)  2
Psychiatric disorders     
Anxiety  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Depression  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Renal and urinary disorders     
Urinary tract obstruction  1  0/94 (0.00%)  0 2/91 (2.20%)  3
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  2/94 (2.13%)  2 0/91 (0.00%)  0
Cough  1  1/94 (1.06%)  2 0/91 (0.00%)  0
Dyspnea  1  3/94 (3.19%)  4 3/91 (3.30%)  3
Hypoxia  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Pleural effusion  1  1/94 (1.06%)  1 2/91 (2.20%)  2
Pneumonitis  1  0/94 (0.00%)  0 2/91 (2.20%)  2
Pneumothorax  1  0/94 (0.00%)  0 1/91 (1.10%)  1
Respiratory failure  1  1/94 (1.06%)  1 1/91 (1.10%)  1
Wheezing  1  1/94 (1.06%)  2 0/91 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  7/94 (7.45%)  11 4/91 (4.40%)  7
Dry skin  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Hyperhidrosis  1  0/94 (0.00%)  0 1/91 (1.10%)  2
Pruritus  1  1/94 (1.06%)  1 1/91 (1.10%)  1
Rash maculo-papular  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Urticaria  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Vascular disorders     
Hot flashes  1  1/94 (1.06%)  1 0/91 (0.00%)  0
Hypertension  1  1/94 (1.06%)  2 6/91 (6.59%)  7
Hypotension  1  0/94 (0.00%)  0 1/91 (1.10%)  2
Thromboembolic event  1  5/94 (5.32%)  6 1/91 (1.10%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Charles L. Loprinzi M.D.
Organization: Mayo Clinic
Phone: 507/284-1623
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02311907     History of Changes
Obsolete Identifiers: NCT00979082
Other Study ID Numbers: N08CA
NCI-2011-01965 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000654097
U10CA037404 ( U.S. NIH Grant/Contract )
First Submitted: December 8, 2014
First Posted: December 9, 2014
Results First Submitted: July 19, 2016
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017