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Trial record 16 of 2062 for:    Pancreatic Cancer AND Digestive System Neoplasms

Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic 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: NCT01555489
Recruitment Status : Terminated (Slow accrual)
First Posted : March 15, 2012
Results First Posted : August 28, 2018
Last Update Posted : August 28, 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 Pancreatic Cancer
Intervention Drug: Ascorbic Acid
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ascorbic Acid, Gemcitabine & Erlotinib
Hide Arm/Group Description

Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Ascorbic Acid: 3x per week

Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Ascorbic Acid, Gemcitabine & Erlotinib
Hide Arm/Group Description

Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Ascorbic Acid: 3x per week

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  54.5%
>=65 years
5
  45.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
3
  27.3%
Male
8
  72.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
11
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 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
1
   9.1%
White
10
  90.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer
Hide Description Safety: to assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants.
Time Frame 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.
Arm/Group Title Ascorbic Acid, Gemcitabine & Erlotinib
Hide Arm/Group Description:

Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Ascorbic Acid: 3x per week

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument
Hide Description 1) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations.
Time Frame 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.
Arm/Group Title Ascorbic Acid, Gemcitabine & Erlotinib
Hide Arm/Group Description:

Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Ascorbic Acid: 3x per week

Overall Number of Participants Analyzed 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, Gemcitabine & Erlotinib
Hide Arm/Group Description

Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Ascorbic Acid: 3x per week

All-Cause Mortality
Ascorbic Acid, Gemcitabine & Erlotinib
Affected / at Risk (%)
Total   1/11 (9.09%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ascorbic Acid, Gemcitabine & Erlotinib
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
General disorders   
Death *  1/11 (9.09%)  1
*
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 5%
Ascorbic Acid, Gemcitabine & Erlotinib
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
Low hemoglobin *  2/11 (18.18%)  2
Low platelets *  2/11 (18.18%)  3
Increased creatinine *  1/11 (9.09%)  1
Low Potassium *  1/11 (9.09%)  1
Cardiac disorders   
Cardiac Infarction *  1/11 (9.09%)  1
Ear and labyrinth disorders   
Tinnitus *  1/11 (9.09%)  1
Gastrointestinal disorders   
Diarrhea *  1/11 (9.09%)  1
GI Obstruction *  1/11 (9.09%)  1
General disorders   
Nausea *  1/11 (9.09%)  1
Immune system disorders   
Infection with normal ANC *  1/11 (9.09%)  1
Sepsis *  1/11 (9.09%)  1
*
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: NCT01555489     History of Changes
Other Study ID Numbers: 11D.365
First Submitted: February 22, 2012
First Posted: March 15, 2012
Results First Submitted: June 29, 2018
Results First Posted: August 28, 2018
Last Update Posted: August 28, 2018