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Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA

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ClinicalTrials.gov Identifier: NCT01550510
Recruitment Status : Terminated (Closed: low enrollment, many treatment options available for Colorectal Cancer)
First Posted : March 12, 2012
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stage IV Colorectal Cancer
Intervention: Drug: Ascorbic Acid

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ascorbic Acid

Ascorbic Acid (50-100g, 3x weekly)

Ascorbic Acid: 3x a week for 9 weeks


Participant Flow:   Overall Study
    Ascorbic Acid
STARTED   4 
COMPLETED   4 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Ascorbic Acid

Ascorbic Acid (50-100g, 3x weekly)

Ascorbic Acid: 3x a week for 9 weeks


Baseline Measures
   Ascorbic Acid 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1  25.0% 
>=65 years      3  75.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  75.0% 
Male      1  25.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      4 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2  50.0% 
White      1  25.0% 
More than one race      0   0.0% 
Unknown or Not Reported      1  25.0% 
Region of Enrollment 
[Units: Participants]
 
United States   4 


  Outcome Measures

1.  Primary:   Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.   [ Time Frame: 9 weeks +/- 2 weeks ]

2.  Secondary:   Number of Participants That Are Alive After 11 Weeks.   [ Time Frame: 9 weeks +/- 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Daniel Monti
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
phone: 215 955-2221
e-mail: daniel.monti@jefferson.edu



Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01550510     History of Changes
Other Study ID Numbers: 11D.459
First Submitted: February 23, 2012
First Posted: March 12, 2012
Results First Submitted: June 25, 2018
Results First Posted: August 24, 2018
Last Update Posted: August 24, 2018