Trial Outcomes & Findings for Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery (NCT NCT02896907)
NCT ID: NCT02896907
Last Updated: 2025-04-30
Results Overview
After 4 patients are enrolled on the study and receive at least one dose of intravenous ascorbic acid, the data will be reviewed. If 2 out of the 4 cannot complete 2 courses of FOLFIRINOX then the study will be halted.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Up to 28 days after the last treatment
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Treatment (FOLFIRINOX, Ascorbic Acid)
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin: Given IV
Irinotecan Hydrochloride: Given IV
Leucovorin Calcium: Given IV
Fluorouracil: Given IV
Ascorbic Acid: Given IV
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment (FOLFIRINOX, Ascorbic Acid)
n=8 Participants
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin: Given IV
Irinotecan Hydrochloride: Given IV
Leucovorin Calcium: Given IV
Fluorouracil: Given IV
Ascorbic Acid: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 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
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after the last treatmentAfter 4 patients are enrolled on the study and receive at least one dose of intravenous ascorbic acid, the data will be reviewed. If 2 out of the 4 cannot complete 2 courses of FOLFIRINOX then the study will be halted.
Outcome measures
| Measure |
Treatment (FOLFIRINOX, Ascorbic Acid)
n=8 Participants
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin: Given IV
Irinotecan Hydrochloride: Given IV
Leucovorin Calcium: Given IV
Fluorouracil: Given IV
Ascorbic Acid: Given IV
|
|---|---|
|
Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
Grade 4 adverse event
|
1 Participants
|
|
Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
Grade 5 adverse event
|
1 Participants
|
|
Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
Grade 3 adverse event
|
4 Participants
|
|
Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
No Serious Adverse Events
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to 28 days after the last treatmentChange in quality of life over the six measurement times will be modeled using mixed effects linear regression to account for correlation among repeated measurements from the same subjects. Average change in QoL from baseline to follow-up will be computed.
Outcome measures
| Measure |
Treatment (FOLFIRINOX, Ascorbic Acid)
n=8 Participants
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin: Given IV
Irinotecan Hydrochloride: Given IV
Leucovorin Calcium: Given IV
Fluorouracil: Given IV
Ascorbic Acid: Given IV
|
|---|---|
|
Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30
|
NA score on a scale
Standard Deviation NA
Due to the small number of participants, quality of life assessments were not looked at quantitatively. Attempts have been made to obtain additional information from the investigator but no information has been provided.
|
Adverse Events
Treatment (FOLFIRINOX, Ascorbic Acid)
Serious events: 6 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Treatment (FOLFIRINOX, Ascorbic Acid)
n=8 participants at risk
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin: Given IV
Irinotecan Hydrochloride: Given IV
Leucovorin Calcium: Given IV
Fluorouracil: Given IV
Ascorbic Acid: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Sepsis
|
12.5%
1/8 • baseline through 30 days after completing treatment; an average of 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
12.5%
1/8 • baseline through 30 days after completing treatment; an average of 4 months.
|
|
General disorders
Hypokalemia
|
50.0%
4/8 • baseline through 30 days after completing treatment; an average of 4 months.
|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
3/8 • baseline through 30 days after completing treatment; an average of 4 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • baseline through 30 days after completing treatment; an average of 4 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. James Posey
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-503-6442
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place