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Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity Caused By Oxaliplatin in Patients Receiving Combination Chemotherapy for Stage II, Stage III, or Stage IV Colorectal Cancer That Has Been Completely Removed By Surgery

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Information provided by (Responsible Party):
Alliance for Clinical Oncology Trials
ClinicalTrials.gov Identifier:
NCT00316914
First received: April 19, 2006
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
Results First Received: November 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Colorectal Cancer
Neurotoxicity
Interventions: Drug: calcium gluconate
Drug: magnesium sulfate
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One-hundred and four (104) participants were recruited between January 2006 and June 2007 from 20 North Central Cancer Treatment Group (NCCTG) member sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants in Calcium/Magnesium arm canceled prior to study medication begins. These two participants were excluded from all analysis.

Reporting Groups
  Description
Ca/Mg Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
Placebo Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.

Participant Flow:   Overall Study
    Ca/Mg     Placebo  
STARTED     50     52  
COMPLETED     17     16  
NOT COMPLETED     33     36  
Withdrawal by Subject                 5                 3  
Adverse Event                 8                 7  
Other Problems                 6                 11  
Missing end of treatment documentation                 14                 15  



  Baseline Characteristics
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Reporting Groups
  Description
Ca/Mg Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
Placebo Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
Total Total of all reporting groups

Baseline Measures
    Ca/Mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  50     52     102  
Age, Customized  
[units: Participants]
 		     
<65     33     33     66  
>=65     17     19     36  
Gender  
[units: participants]
 		     
Female     23     25     48  
Male     27     27     54  
Race (NIH/OMB)  
[units: Participants]
 		     
American Indian or Alaska Native     0     1     1  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     48     50     98  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
 		     
United States     50     52     102  
Regimen  
[units: Participants]
 		     
FOLFOX4 (Oxaliplatin, Leucovorin, and Fluorouracil     3     3     6  
Modified FOLFOX6     47     49     96  



  Outcome Measures
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1.  Primary:   Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event   [ Time Frame: 127 days ]
  Show Outcome Measure 1

2.  Secondary:   Time to Onset of Grade 2+ Chronic Neurotoxicity   [ Time Frame: 127 days ]
  Show Outcome Measure 2

3.  Secondary:   Time to Onset of Grade 3+ Chronic Neurotoxicity   [ Time Frame: 127 days ]
  Show Outcome Measure 3

4.  Secondary:   Average Duration of Chronic Neuropathic Toxicity   [ Time Frame: 127 days ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity   [ Time Frame: 127 days ]
  Show Outcome Measure 5

6.  Secondary:   Average Cumulative Oxaliplatin Dose   [ Time Frame: 127 days ]
  Show Outcome Measure 6

7.  Secondary:   Average Duration of Oxaliplatin-containing Treatment   [ Time Frame: 127 days ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Patients With Acute Neuropathic Adverse Event   [ Time Frame: 127 days ]
  Show Outcome Measure 8

9.  Secondary:   Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event   [ Time Frame: 127 days ]
  Show Outcome Measure 9

10.  Secondary:   Percentage of Patients Experiencing Impact on Activities of Daily Living (ADL)   [ Time Frame: 127 days ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in Fatigue Score at One Month   [ Time Frame: Baseline and One month ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Quality of Life (QOL) at One Month   [ Time Frame: Baseline and One month ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Data cutoff was done after 127 days because of premature study closure and because of the protocol modification mandating that the Ca/Mg therapy be discontinued.  


Results Point of Contact:  
Name/Title: Dr. Axel Grothey
Organization: Mayo Clinic
phone: 507-184-2779
e-mail: grothey.axel@mayo.edu


Publications of Results:
Nikcevich DA, Grothey A, Sloan JA, et al.: Effect of intravenous calcium and magnesium (IV CaMg) on oxaliplatin-induced sensory neurotoxicity (sNT) in adjuvant colon cancer: results of the phase III placebo-controlled, double-blind NCCTG trial N04C7. [Abstract] J Clin Oncol 26 (Suppl 15): A-4009, 2008.


Responsible Party: Alliance for Clinical Oncology Trials
ClinicalTrials.gov Identifier: NCT00316914     History of Changes
Other Study ID Numbers: CDR0000471238, NCCTG-N04C7
Study First Received: April 19, 2006
Results First Received: November 26, 2012
Last Updated: February 19, 2013
Health Authority: United States: Federal Government