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Trial record 21 of 104 for:    colon cancer | ( Map: Nebraska, United States )

Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01099449
Recruitment Status : Completed
First Posted : April 7, 2010
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
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: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Chemotherapeutic Agent Toxicity
Colorectal Cancer
Neuropathy
Neurotoxicity
Interventions Drug: calcium gluconate
Drug: magnesium sulfate
Other: placebo
Drug: oxaliplatin
Enrollment 362
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Hide Arm/Group Description Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Period Title: Overall Study
Started [1] 118 119 116
Completed 118 119 116
Not Completed 0 0 0
[1]
Nine patients were deemed ineligible or withdrew prior to randomization.
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) Total
Hide Arm/Group Description

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). >>

>> calcium gluconate: Given IV >>

>> magnesium sulfate: Given IV >>

>> oxaliplatin

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). >> >> placebo: Given IV >>

>> oxaliplatin

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy). >>

>> calcium gluconate: Given IV >>

>> magnesium sulfate: Given IV >>

>> placebo: Given IV >>

  • >> oxaliplatin
Total of all reporting groups
Overall Number of Baseline Participants 118 119 116 353
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 118 participants 119 participants 116 participants 353 participants
57
(49 to 65)
56
(49 to 65)
57
(50.5 to 64.5)
56
(50 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 119 participants 116 participants 353 participants
Female
62
  52.5%
62
  52.1%
60
  51.7%
184
  52.1%
Male
56
  47.5%
57
  47.9%
56
  48.3%
169
  47.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 119 participants 116 participants 353 participants
Ecuador
0
   0.0%
1
   0.8%
0
   0.0%
1
   0.3%
United States
118
 100.0%
118
  99.2%
116
 100.0%
352
  99.7%
1.Primary Outcome
Title Sensory Area Under the Curve(AUC) Score. Oxaliplatin-induced Sensory Neuropathy as Repeatedly Measured by the EORTC QLQ-CIPN20 Sensory Subscale During Chemotherapy
Hide Description The oxaliplatin-induced sensory neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) sensory subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 sensory subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 sensory subscale as the primary endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients with Baseline and more than 1 cycle of Sensory data.
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Hide Arm/Group Description:

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). >

  • > >
  • > > calcium gluconate: Given IV >
  • > >
  • > > magnesium sulfate: Given IV >
  • > >
  • > > oxaliplatin

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). >

  • > >
  • > > placebo: Given IV >
  • > >
  • > > oxaliplatin

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy). >

  • > >
  • > > calcium gluconate: Given IV >
  • > >
  • > > magnesium sulfate: Given IV >
  • > >
  • > > placebo: Given IV >
  • > >
  • > > oxaliplatin
Overall Number of Participants Analyzed 110 106 110
Mean (Standard Deviation)
Unit of Measure: score on a scale
89.2  (8.5) 88.3  (9.7) 87.1  (9.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
Comments Two-sample t-tests or Wilcoxon rank-sum tests will be used >> to compare the AUC of CIPN sensory subscale between each of the two schedules of >> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory >> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory >> subscale scores from the AUC or incorporate them as a covariate in generalized linear >> regression model.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.
Statistical Test of Hypothesis P-Value .73
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Comments Two-sample t-tests or Wilcoxon rank-sum tests will be used >> to compare the AUC of CIPN sensory subscale between each of the two schedules of >> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory >> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory >> subscale scores from the AUC or incorporate them as a covariate in generalized linear >> regression model.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.
Statistical Test of Hypothesis P-Value .29
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Area Under the Curve (AUC) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Autonomic Neuropathy Subscale Scores
Hide Description The oxaliplatin-induced autonomic neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) autonomic subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN autonomic subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 autonomic subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 autonomic subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with Baseline and more than one cycle of EORTC CIPN-20 Autonomic data.
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Hide Arm/Group Description:

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). >

  • > >
  • > > calcium gluconate: Given IV >
  • > >
  • > > magnesium sulfate: Given IV >
  • > >
  • > > oxaliplatin

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). >

  • > >
  • > > placebo: Given IV >
  • > >
  • > > oxaliplatin

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy). >

  • > >
  • > > calcium gluconate: Given IV >
  • > >
  • > > magnesium sulfate: Given IV >
  • > >
  • > > placebo: Given IV >
  • > >
  • > > oxaliplatin
Overall Number of Participants Analyzed 108 102 111
Mean (Standard Deviation)
Unit of Measure: score on a scale
89.8  (12.5) 86.7  (14.3) 84.5  (15.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
Comments We will not adjust p-values (or significance level) for multiple >> comparisons among the numerous hypothesis testings of secondary endpoints due to the >> exploratory nature of these secondary analyses. The significance results from secondary >> analyses will be interpreted cautiously in a hypothesis-generating fashion.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.
Statistical Test of Hypothesis P-Value .054
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Comments We will not adjust p-values (or significance level) for multiple >> comparisons among the numerous hypothesis testings of secondary endpoints due to the >> exploratory nature of these secondary analyses. The significance results from secondary >> analyses will be interpreted cautiously in a hypothesis-generating fashion.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.
Statistical Test of Hypothesis P-Value .27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Curve (AUC) of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Motor Neuropathy Subscale Scores
Hide Description The oxaliplatin-induced motor neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) motor neuropathy subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN motor neuropathy subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 motor neuropathy subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 motor neuropathy subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.
Time Frame Up to 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with at least baseline and more than 1 cycle of Motor Neuropathy data.
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Hide Arm/Group Description:

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). >>

>> calcium gluconate: Given IV >>

>> magnesium sulfate: Given IV >>

>> oxaliplatin

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). >> >> placebo: Given IV >>

>> oxaliplatin

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy). >> >> calcium gluconate: Given IV >>

>> magnesium sulfate: Given IV >>

>> placebo: Given IV >>

>> oxaliplatin

Overall Number of Participants Analyzed 110 106 110
Mean (Standard Deviation)
Unit of Measure: AUC QLQ-CIPN20 Motor Neuropathy Score
94.1  (7.9) 93.3  (8.0) 91.6  (10.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
Comments We will not adjust p-values (or significance level) for multiple >> comparisons among the numerous hypothesis testings of secondary endpoints due to the >> exploratory nature of these secondary analyses. The significance results from secondary >> analyses will be interpreted cautiously in a hypothesis-generating fashion.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.
Statistical Test of Hypothesis P-Value .29
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Comments We will not adjust p-values (or significance level) for multiple >> comparisons among the numerous hypothesis testings of secondary endpoints due to the >> exploratory nature of these secondary analyses. The significance results from secondary >> analyses will be interpreted cautiously in a hypothesis-generating fashion.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.
Statistical Test of Hypothesis P-Value .25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Patients Experiencing Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity.
Hide Description Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that under went at least one cycle of treatment and were analyzed for chronic cumulative neurotoxicity (NCI CTCAE version 4.0 and oxaliplatin-specific neurotoxicity scale) during and after chemotherapy
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Hide Arm/Group Description:
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Overall Number of Participants Analyzed 118 119 116
Measure Type: Number
Unit of Measure: percentage of patients
grade 2+ 42.7 44.8 46.1
grade 3+ 7.7 7.8 7.8
5.Secondary Outcome
Title Time to Onset of Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity and the Duration of the Chronic Cumulative Neurotoxicity During and After Chemotherapy
Hide Description Time to onset of grade 2+ and grade 3+ chronic cumulative neurotoxicity, the duration of the chronic cumulative neurotoxicity during and after the adjuvant oxaliplatin-based chemotherapy. Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Hide Arm/Group Description:
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Overall Number of Participants Analyzed 109 108 105
Median (Inter-Quartile Range)
Unit of Measure: Days
Time to Grade 2 Neuropathy
171
(154 to 190)
173
(162 to 181)
171
(148 to 173)
Time to Grade 3 Neuropathy
NA [1] 
(209 to NA)
208 [1] 
(200 to NA)
NA [1] 
(201 to NA)
[1]
Not Reached
6.Secondary Outcome
Title Cumulative Oxaliplatin Doses That Can be Administered Without Dose-limiting Chronic Neurotoxicity
Hide Description A patient has a dose-limiting chronic neurotoxicity when they discontinue oxaliplatin-based chemotherapy because of neurotoxicity.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that discontinued treatment.
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Hide Arm/Group Description:
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Overall Number of Participants Analyzed 34 32 28
Mean (Standard Deviation)
Unit of Measure: Doses
8.1  (3) 8.4  (2.5) 8.0  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Kruskal Wallis Analysis
Statistical Test of Hypothesis P-Value .89
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Kruskal Wallis Analysis
Statistical Test of Hypothesis P-Value .496
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Patients Discontinuing Oxaliplatin-based Chemotherapy Because of Neurotoxicity
Hide Description [Not Specified]
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received treatment.
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Hide Arm/Group Description:

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). > >

  • calcium gluconate: Given IV > >
  • magnesium sulfate: Given IV > >
  • oxaliplatin
Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
Overall Number of Participants Analyzed 118 119 116
Measure Type: Number
Unit of Measure: percentage of patients
34.7 27.7 30.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcium Gluconate + Magnesium Sulfate (Pre and Post), Placebo (Pre and Post)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Chi-Squared Analysis
Statistical Test of Hypothesis P-Value .52
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Pre and Post), Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Chi-Squared Analysis
Statistical Test of Hypothesis P-Value .66
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Patients With Acute Neuropathy Associated With Oxaliplatin
Hide Description This is the percent of patients who scored >=50 in all sequences of all cycles by arm for side effect Q1: Sensitivity to touching cold. This is a > repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Where 0 is no sensitivity and 100 is as bad as it can be.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). >

  • > >
  • > > calcium gluconate: Given IV >
  • > >
  • > > magnesium sulfate: Given IV >
  • > >
  • > > oxaliplatin

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). >

  • > >
  • > > placebo: Given IV >
  • > >
  • > > oxaliplatin

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy). >

  • > >
  • > > calcium gluconate: Given IV >
  • > >
  • > > magnesium sulfate: Given IV >
  • > >
  • > > placebo: Given IV >
  • > >
  • > > oxaliplatin
Overall Number of Participants Analyzed 110 106 110
Measure Type: Number
Unit of Measure: percentage of patients
Cycle 1 10 13 14
Cycle 2 24 27 28
Cycle 3 32 33 32
Cycle 4 34 37 36
Cycle 5 34 33 39
Cycle 6 31 37 33
Cycle 7 35 34 34
Cycle 8 32 34 33
Cycle 9 34 37 32
Cycle 10 29 39 30
Cycle 11 28 39 33
Cycle 12 27 45 32
9.Secondary Outcome
Title Incidence of Calcium Gluconate and Magnesium Sulfate-induced Adverse Events as Measured by CTCAE Version 4.0
Hide Description [Not Specified]
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). >>

>> calcium gluconate: Given IV >>

>> magnesium sulfate: Given IV >>

>> oxaliplatin

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). >> >> placebo: Given IV >>

>> oxaliplatin

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy). >> >> calcium gluconate: Given IV >>

>> magnesium sulfate: Given IV >>

>> placebo: Given IV >>

>> oxaliplatin

Overall Number of Participants Analyzed 118 119 116
Measure Type: Number
Unit of Measure: Number of reported Adverse Events
290 259 296
10.Secondary Outcome
Title Area Under the Curve (AUC) of Patient-reported Quality of Life (QOL) as Measured by the Supplemental QOL Questionnaire
Hide Description This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The supplemental quality of life (QOL) subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) . This AUC will be prorated by the number of chemotherapy cycles patients received.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that had at least one cycle of treatment and submitted a patient-reported quality of life (QOL) as measured by the supplemental QOL questionnaire
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). >

  • > >
  • > > calcium gluconate: Given IV >
  • > >
  • > > magnesium sulfate: Given IV >
  • > >
  • > > oxaliplatin

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy). >

  • > >
  • > > placebo: Given IV >
  • > >
  • > > oxaliplatin

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy). >

  • > >
  • > > calcium gluconate: Given IV >
  • > >
  • > > magnesium sulfate: Given IV >
  • > >
  • > > placebo: Given IV >
  • > >
  • > > oxaliplatin
Overall Number of Participants Analyzed 111 112 108
Mean (Standard Deviation)
Unit of Measure: score on a scale
Diarrhea 86.7  (15.5) 86.2  (15.7) 84.5  (16)
Constipation 90.1  (13.0) 88.8  (13.4) 88.0  (18.8)
Stomach Cramping 92.8  (11.4) 90.6  (12.6) 89.4  (15.6)
Bowel Problems 89.1  (13.4) 88.5  (14.4) 84.6  (19.0)
Swallowing 91.2  (10.0) 87.6  (13.8) 86.7  (14.1)
Numbness in finger and toes 83.4  (14.8) 81.8  (15.7) 80.0  (17.3)
Tingling in finger and toes 78.9  (16.5) 76.5  (17.3) 76.3  (17.6)
Time Frame 3 years
Adverse Event Reporting Description This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for adverse event monitoring and reporting. The CTCAE version 4.0 can be accessed from the CTEP home page (http://ctep.cancer.gov).
 
Arm/Group Title Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Hide Arm/Group Description oxaliplatin oxaliplatin oxaliplatin
All-Cause Mortality
Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/117 (11.11%)      9/119 (7.56%)      8/116 (6.90%)    
Blood and lymphatic system disorders       
Febrile neutropenia  1  1/117 (0.85%)  1 1/119 (0.84%)  1 0/116 (0.00%)  0
Cardiac disorders       
Atrial flutter  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Gastrointestinal disorders       
Abdominal pain  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Constipation  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Diarrhea  1  9/117 (7.69%)  13 3/119 (2.52%)  3 3/116 (2.59%)  3
Nausea  1  3/117 (2.56%)  5 0/119 (0.00%)  0 3/116 (2.59%)  6
Small intestinal obstruction  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Vomiting  1  1/117 (0.85%)  1 0/119 (0.00%)  0 1/116 (0.86%)  1
General disorders       
Fatigue  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Fever  1  1/117 (0.85%)  2 0/119 (0.00%)  0 0/116 (0.00%)  0
Infections and infestations       
Abdominal infection  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Bronchial infection  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Urinary tract infection  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Injury, poisoning and procedural complications       
Infusion related reaction  1  2/117 (1.71%)  2 0/119 (0.00%)  0 0/116 (0.00%)  0
Investigations       
Alkaline phosphatase increased  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Neutrophil count decreased  1  0/117 (0.00%)  0 3/119 (2.52%)  4 1/116 (0.86%)  1
Platelet count decreased  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Metabolism and nutrition disorders       
Hypokalemia  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Nervous system disorders       
Peripheral sensory neuropathy  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Transient ischemic attacks  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Psychiatric disorders       
Anxiety  1  0/117 (0.00%)  0 1/119 (0.84%)  5 0/116 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonitis  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (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%
Calcium Gluconate + Magnesium Sulfate (Pre and Post) Placebo (Pre and Post) Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   107/117 (91.45%)      108/119 (90.76%)      105/116 (90.52%)    
Blood and lymphatic system disorders       
Anemia  1  1/117 (0.85%)  4 2/119 (1.68%)  7 4/116 (3.45%)  6
Disseminated intravascular coagulation  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Febrile neutropenia  1  2/117 (1.71%)  3 4/119 (3.36%)  4 4/116 (3.45%)  4
Thrombotic thrombocytopenic purpura  1  0/117 (0.00%)  0 0/119 (0.00%)  0 2/116 (1.72%)  2
Cardiac disorders       
Acute coronary syndrome  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Atrial fibrillation  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Sick sinus syndrome  1  0/117 (0.00%)  0 1/119 (0.84%)  3 0/116 (0.00%)  0
Supraventricular tachycardia  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Ventricular tachycardia  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Eye disorders       
Blurred vision  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Cataract  1  1/117 (0.85%)  2 0/119 (0.00%)  0 0/116 (0.00%)  0
Eye disorders - Other, specify  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Gastrointestinal disorders       
Abdominal pain  1  2/117 (1.71%)  3 3/119 (2.52%)  14 2/116 (1.72%)  4
Colitis  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Colonic obstruction  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Constipation  1  3/117 (2.56%)  5 4/119 (3.36%)  8 4/116 (3.45%)  6
Diarrhea  1  80/117 (68.38%)  315 73/119 (61.34%)  325 77/116 (66.38%)  363
Dysphagia  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Enterocolitis  1  1/117 (0.85%)  1 0/119 (0.00%)  0 1/116 (0.86%)  1
Esophagitis  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Flatulence  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Gastritis  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Gastroesophageal reflux disease  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Gastrointestinal disorders - Oth spec  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Gastrointestinal pain  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Hemorrhoidal hemorrhage  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Ileal obstruction  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Lower gastrointestinal hemorrhage  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Mucositis oral  1  2/117 (1.71%)  2 5/119 (4.20%)  5 4/116 (3.45%)  5
Nausea  1  86/117 (73.50%)  351 78/119 (65.55%)  346 78/116 (67.24%)  377
Pancreatitis  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Rectal mucositis  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Rectal pain  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Small intestinal obstruction  1  1/117 (0.85%)  1 0/119 (0.00%)  0 1/116 (0.86%)  1
Typhlitis  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Vomiting  1  42/117 (35.90%)  70 30/119 (25.21%)  55 33/116 (28.45%)  84
General disorders       
Fatigue  1  9/117 (7.69%)  22 13/119 (10.92%)  32 13/116 (11.21%)  30
Fever  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Non-cardiac chest pain  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Pain  1  0/117 (0.00%)  0 2/119 (1.68%)  2 0/116 (0.00%)  0
Immune system disorders       
Allergic reaction  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Infections and infestations       
Abdominal infection  1  1/117 (0.85%)  2 1/119 (0.84%)  1 0/116 (0.00%)  0
Anorectal infection  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Bladder infection  1  1/117 (0.85%)  1 1/119 (0.84%)  1 0/116 (0.00%)  0
Bronchial infection  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Bronchitis(unknown ANC)  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Catheter related infection  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Enterocolitis infectious  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Infections and infestations - Oth spec  1  1/117 (0.85%)  2 0/119 (0.00%)  0 0/116 (0.00%)  0
Lung infection  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Mucosal infection  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Otitis media  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Sepsis  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Skin infection  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Soft tissue infection  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Upper respiratory infection  1  1/117 (0.85%)  1 1/119 (0.84%)  1 0/116 (0.00%)  0
Urinary tract infection  1  0/117 (0.00%)  0 4/119 (3.36%)  5 0/116 (0.00%)  0
Wound infection  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Injury, poisoning and procedural complications       
Infusion related reaction  1  1/117 (0.85%)  1 2/119 (1.68%)  2 1/116 (0.86%)  1
Investigations       
Alanine aminotransferase increased  1  2/117 (1.71%)  2 1/119 (0.84%)  1 1/116 (0.86%)  1
Alkaline phosphatase increased  1  1/117 (0.85%)  2 2/119 (1.68%)  9 0/116 (0.00%)  0
Aspartate aminotransferase increased  1  2/117 (1.71%)  2 1/119 (0.84%)  2 0/116 (0.00%)  0
Creatinine increased  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Hemoglobin increased  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
INR increased  1  1/117 (0.85%)  9 1/119 (0.84%)  1 0/116 (0.00%)  0
Lipase increased  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Lymphocyte count decreased  1  2/117 (1.71%)  2 2/119 (1.68%)  3 2/116 (1.72%)  2
Neutrophil count decreased  1  28/117 (23.93%)  54 28/119 (23.53%)  51 32/116 (27.59%)  67
Platelet count decreased  1  8/117 (6.84%)  18 8/119 (6.72%)  15 8/116 (6.90%)  16
Weight gain  1  1/117 (0.85%)  2 0/119 (0.00%)  0 0/116 (0.00%)  0
White blood cell decreased  1  13/117 (11.11%)  20 10/119 (8.40%)  17 14/116 (12.07%)  21
Metabolism and nutrition disorders       
Anorexia  1  2/117 (1.71%)  2 2/119 (1.68%)  2 1/116 (0.86%)  1
Dehydration  1  2/117 (1.71%)  2 5/119 (4.20%)  5 3/116 (2.59%)  3
Hyperglycemia  1  3/117 (2.56%)  5 2/119 (1.68%)  2 1/116 (0.86%)  2
Hyperkalemia  1  0/117 (0.00%)  0 0/119 (0.00%)  0 2/116 (1.72%)  2
Hypernatremia  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Hypertriglyceridemia  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  3
Hypoalbuminemia  1  0/117 (0.00%)  0 1/119 (0.84%)  1 1/116 (0.86%)  1
Hypocalcemia  1  0/117 (0.00%)  0 0/119 (0.00%)  0 2/116 (1.72%)  2
Hypoglycemia  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Hypokalemia  1  3/117 (2.56%)  3 4/119 (3.36%)  4 2/116 (1.72%)  3
Hyponatremia  1  1/117 (0.85%)  5 1/119 (0.84%)  1 1/116 (0.86%)  1
Hypophosphatemia  1  0/117 (0.00%)  0 2/119 (1.68%)  2 0/116 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Generalized muscle weakness  1  2/117 (1.71%)  3 0/119 (0.00%)  0 0/116 (0.00%)  0
Joint range of motion decreased  1  1/117 (0.85%)  2 0/119 (0.00%)  0 0/116 (0.00%)  0
Neck pain  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Pain in extremity  1  0/117 (0.00%)  0 1/119 (0.84%)  1 1/116 (0.86%)  1
Nervous system disorders       
Ataxia  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Cognitive disturbance  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Dizziness  1  2/117 (1.71%)  3 0/119 (0.00%)  0 1/116 (0.86%)  1
Dysesthesia  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Dysgeusia  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Headache  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Paresthesia  1  0/117 (0.00%)  0 2/119 (1.68%)  3 1/116 (0.86%)  1
Peripheral motor neuropathy  1  2/117 (1.71%)  2 2/119 (1.68%)  3 2/116 (1.72%)  2
Peripheral sensory neuropathy  1  14/117 (11.97%)  33 12/119 (10.08%)  23 10/116 (8.62%)  18
Stroke  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Tremor  1  1/117 (0.85%)  2 0/119 (0.00%)  0 0/116 (0.00%)  0
Psychiatric disorders       
Anxiety  1  1/117 (0.85%)  2 1/119 (0.84%)  2 0/116 (0.00%)  0
Depression  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Insomnia  1  1/117 (0.85%)  1 2/119 (1.68%)  2 1/116 (0.86%)  4
Renal and urinary disorders       
Chronic kidney disease  1  1/117 (0.85%)  2 0/119 (0.00%)  0 0/116 (0.00%)  0
Hematuria  1  0/117 (0.00%)  0 2/119 (1.68%)  2 0/116 (0.00%)  0
Proteinuria  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Renal and urinary disorders - Oth spec  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  2
Respiratory, thoracic and mediastinal disorders       
Bronchial stricture  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Cough  1  1/117 (0.85%)  1 1/119 (0.84%)  1 0/116 (0.00%)  0
Dyspnea  1  0/117 (0.00%)  0 2/119 (1.68%)  2 0/116 (0.00%)  0
Laryngopharyngeal dysesthesia  1  0/117 (0.00%)  0 0/119 (0.00%)  0 2/116 (1.72%)  2
Pharyngeal mucositis  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Pneumonitis  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Productive cough  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Respiratory failure  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Wheezing  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  0/117 (0.00%)  0 0/119 (0.00%)  0 1/116 (0.86%)  1
Palmar-plantar erythrodysesthesia syndrm  1  1/117 (0.85%)  3 0/119 (0.00%)  0 2/116 (1.72%)  3
Pruritus  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Skin and subcut tissue disord - Oth spec  1  1/117 (0.85%)  2 1/119 (0.84%)  1 0/116 (0.00%)  0
Surgical and medical procedures       
Surgical and medical proced - Oth spec  1  1/117 (0.85%)  2 0/119 (0.00%)  0 0/116 (0.00%)  0
Vascular disorders       
Flushing  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
Hot flashes  1  0/117 (0.00%)  0 1/119 (0.84%)  3 0/116 (0.00%)  0
Hypertension  1  2/117 (1.71%)  8 3/119 (2.52%)  4 2/116 (1.72%)  9
Hypotension  1  2/117 (1.71%)  2 3/119 (2.52%)  3 2/116 (1.72%)  2
Superficial thrombophlebitis  1  1/117 (0.85%)  1 0/119 (0.00%)  0 0/116 (0.00%)  0
Thromboembolic event  1  4/117 (3.42%)  14 3/119 (2.52%)  4 5/116 (4.31%)  10
Vascular disorders - Other, specify  1  0/117 (0.00%)  0 1/119 (0.84%)  1 0/116 (0.00%)  0
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 Loprinzi, M.D.
Organization: Mayo Clinic
Phone: (507) 284-3731
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01099449     History of Changes
Other Study ID Numbers: N08CB
NCCTG-N08CB
CDR0000669660 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-02036 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: April 6, 2010
First Posted: April 7, 2010
Results First Submitted: January 3, 2017
Results First Posted: May 23, 2019
Last Update Posted: May 23, 2019