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Trial record 27 of 3562 for:    colon cancer AND Colonic Diseases

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

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: 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 : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stage IV Colorectal Cancer
Interventions Drug: Ascorbic Acid
Drug: Irinotecan
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ascorbic Acid Standard of Care (Irinotecan Alone)
Hide Arm/Group Description

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

Ascorbic Acid: 3x a week for 9 weeks

350mg/m2 once a week every 3 weeks
Period Title: Overall Study
Started 4 0
Completed 4 0
Not Completed 0 0
Arm/Group Title Ascorbic Acid+Irinotecan Standard of Care (Irinotecan Alone) Total
Hide Arm/Group Description

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

Ascorbic Acid: 3x a week for 9 weeks

350mg/m2 once a week every 3 weeks Total of all reporting groups
Overall Number of Baseline Participants 4 0 4
Hide Baseline Analysis Population Description
The Phase 2 portion of this study never enrolled and therefore no patients were enrolled to the standard of care arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  25.0%
1
  25.0%
>=65 years
3
  75.0%
3
  75.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
Female
3
  75.0%
3
  75.0%
Male
1
  25.0%
1
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
 100.0%
4
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
2
  50.0%
2
  50.0%
White
1
  25.0%
1
  25.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  25.0%
1
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 0 participants 4 participants
4 4
1.Primary Outcome
Title Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Hide Description Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time Frame 9 weeks +/- 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to lack of accrual. The data were not collected or analyzed.
Arm/Group Title Ascorbic Acid+Irinotecan Standard of Care (Irinotecan Alone)
Hide Arm/Group Description:

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

Ascorbic Acid: 3x a week for 9 weeks

350mg/m2 once a week every 3 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants That Are Alive After 11 Weeks.
Hide Description To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer
Time Frame 9 weeks +/- 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to lack of accrual. The data were not collected or analyzed.
Arm/Group Title Ascorbic Acid Standard of Care (Irinotecan Alone)
Hide Arm/Group Description:

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

Ascorbic Acid: 3x a week for 9 weeks

350mg/m2 once a week every 3 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The study was closed early due to lack of accrual. Adverse event data were collected for the patients who were enrolled in the study.
 
Arm/Group Title Ascorbic Acid+Irinotecan Standard of Care (Irinotecan Alone)
Hide Arm/Group Description

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

Ascorbic Acid: 3x a week for 9 weeks

350mg/m2 once a week every 3 weeks
All-Cause Mortality
Ascorbic Acid+Irinotecan Standard of Care (Irinotecan Alone)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/0    
Show Serious Adverse Events Hide Serious Adverse Events
Ascorbic Acid+Irinotecan Standard of Care (Irinotecan Alone)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ascorbic Acid+Irinotecan Standard of Care (Irinotecan Alone)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      0/0    
Blood and lymphatic system disorders     
Hypokalemia   1/4 (25.00%)  1 /0 
Low Hemoglobin   1/4 (25.00%)  1 /0 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Monti
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215 955-2221
EMail: daniel.monti@jefferson.edu
Layout table for additonal information
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: October 9, 2019