Trial Outcomes & Findings for Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca (NCT NCT01555489)
NCT ID: NCT01555489
Last Updated: 2025-05-04
Results Overview
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.
TERMINATED
PHASE2
11 participants
15 weeks
2025-05-04
Participant Flow
Participant milestones
| Measure |
Ascorbic Acid, Gemcitabine & Erlotinib
Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer
Ascorbic Acid: 3x per week
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
Baseline characteristics by cohort
| Measure |
Ascorbic Acid, Gemcitabine & Erlotinib
n=11 Participants
Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer
Ascorbic Acid: 3x per week
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Ascorbic Acid, Gemcitabine & Erlotinib
Serious adverse events
| Measure |
Ascorbic Acid, Gemcitabine & Erlotinib
n=11 participants at risk
Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer
Ascorbic Acid: 3x per week
|
|---|---|
|
General disorders
Death
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
Ascorbic Acid, Gemcitabine & Erlotinib
n=11 participants at risk
Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer
Ascorbic Acid: 3x per week
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
Low hemoglobin
|
18.2%
2/11 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
9.1%
1/11 • Number of events 1
|
|
Immune system disorders
Infection with normal ANC
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
Low platelets
|
18.2%
2/11 • Number of events 3
|
|
Gastrointestinal disorders
GI Obstruction
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
Increased creatinine
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Nausea
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
Low Potassium
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Cardiac Infarction
|
9.1%
1/11 • Number of events 1
|
|
Immune system disorders
Sepsis
|
9.1%
1/11 • Number of events 1
|
Additional Information
Dr. Daniel Monti
Sidney Kimmel Cancer Center at Thomas Jefferson University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place