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Trial record 18 of 4078 for:    colon cancer AND Intestinal Neoplasms

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 : June 6, 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. 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
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
Name/Title: Dr. Daniel Monti
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215 955-2221
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: June 6, 2019