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A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective

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ClinicalTrials.gov Identifier: NCT01754987
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Hepatocellular Carcinoma
Advanced Liver Cancer
Interventions Drug: Ascorbic Acid + Sorafenib
Drug: Sorafenib
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ascorbic Acid + Sorafenib Sorafenib Alone
Hide Arm/Group Description

Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate

Dosage:

Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)

Ascorbic Acid + Sorafenib

Sorafenib: taken daily (oral)

Sorafenib

Period Title: Overall Study
Started 5 0
Completed 5 0
Not Completed 0 0
Arm/Group Title Ascorbic Acid + Sorafenib Sorafenib Alone Total
Hide Arm/Group Description

Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate

Dosage:

Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)

Ascorbic Acid + Sorafenib

Sorafenib: taken daily (oral)

Sorafenib

Total of all reporting groups
Overall Number of Baseline Participants 5 0 5
Hide Baseline Analysis Population Description
The trial was terminated prematurely. No patients were accrued to the Sorafenib arm. Data were not collected
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 0 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  60.0%
3
  60.0%
>=65 years
2
  40.0%
2
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 0 participants 5 participants
Female
2
  40.0%
2
  40.0%
Male
3
  60.0%
3
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 0 participants 5 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
Not Hispanic or Latino
5
 100.0%
5
 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 5 participants 0 participants 5 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
1
  20.0%
1
  20.0%
White
4
  80.0%
4
  80.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 0 participants 5 participants
5 5
1.Primary Outcome
Title Number of Participants That Experience Serious Adverse Events.
Hide Description The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with sorafenib therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE)v4.0
Time Frame 16 weeks +/- 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was closed early due to lack of accrual. The data were not collected or analyzed.
Arm/Group Title Ascorbic Acid + Sorafenib Sorafenib Alone
Hide Arm/Group Description:

Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate

Dosage:

Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)

Ascorbic Acid + Sorafenib

Sorafenib: taken daily (oral)

Sorafenib

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Tumor Response Rate
Hide Description To utilize CT or PET/CT scans to assess overall tumor response rate (complete) in subjects with advanced metastatic hepatocellular cancer treated with the combination of ascorbic acid and sorafenib versus sorafenib alone.
Time Frame 16 weeks +/- 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was closed early due to lack of accrual. The data were not collected or analyzed.
Arm/Group Title Ascorbic Acid + Sorafenib Sorafenib Alone
Hide Arm/Group Description:

Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate

Dosage:

Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)

Ascorbic Acid + Sorafenib

Sorafenib: taken daily (oral)

Sorafenib

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Mean Value Collected Using the Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument
Hide Description To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G will be summarized at multiple time points. Five-point scale from 0 (not at all) to 4 (very much)
Time Frame 16 weeks +/- 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was closed early due to lack of accrual. The data were not collected or analyzed.
Arm/Group Title Ascorbic Acid + Sorafenib Sorafenib Alone
Hide Arm/Group Description:

Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate

Dosage:

Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)

Ascorbic Acid + Sorafenib

Sorafenib: taken daily (oral)

Sorafenib

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants That Are Alive After 15 Weeks of Treatment.
Hide Description To evaluate duration of tumor response and progression-free survival
Time Frame 15 weeks+
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was closed early due to lack of accrual. The data were not collected or analyzed.
Arm/Group Title Ascorbic Acid + Sorafenib Sorafenib Alone
Hide Arm/Group Description:

Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate

Dosage:

Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)

Ascorbic Acid + Sorafenib

Sorafenib: taken daily (oral)

Sorafenib

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 [Not Specified]
 
Arm/Group Title Ascorbic Acid + Sorafenib Sorafenib Alone
Hide Arm/Group Description

Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate

Dosage:

Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)

Ascorbic Acid + Sorafenib

Sorafenib: taken daily (oral)

Sorafenib

All-Cause Mortality
Ascorbic Acid + Sorafenib Sorafenib Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ascorbic Acid + Sorafenib Sorafenib Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/0    
General disorders     
Dehydration *  1/5 (20.00%)  1 0/0  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ascorbic Acid + Sorafenib Sorafenib Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      0/0    
Blood and lymphatic system disorders     
Elevated Creatinine *  2/5 (40.00%)  2 0/0  0
Nosebleed *  1/5 (20.00%)  1 0/0  0
Low Platelet count *  2/5 (40.00%)  2 0/0  0
Infections and infestations     
Thrush *  1/5 (20.00%)  1 0/0  0
*
Indicates events were collected by non-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: NCT01754987     History of Changes
Other Study ID Numbers: 12D.424
First Submitted: December 18, 2012
First Posted: December 21, 2012
Results First Submitted: June 25, 2018
Results First Posted: August 23, 2018
Last Update Posted: August 23, 2018