Trial Outcomes & Findings for Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer (NCT NCT01515046)
NCT ID: NCT01515046
Last Updated: 2017-06-08
Results Overview
Time to event outcome measure (death), measured in days from cycle 1 day 1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
up to 5 years
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
Gemcitabine With Escalating IV Ascorbate
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine With Escalating IV Ascorbate
n=1 Participants
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsTime to event outcome measure (death), measured in days from cycle 1 day 1.
Outcome measures
| Measure |
Gemcitabine With Escalating IV Ascorbate
n=1 Participants
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)
|
|---|---|
|
Overall Survival
|
268 days
|
SECONDARY outcome
Timeframe: up to 5 yearsTime-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST criteria from NCI.
Outcome measures
| Measure |
Gemcitabine With Escalating IV Ascorbate
n=1 Participants
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)
|
|---|---|
|
Progression Free Survival
|
80 days
|
SECONDARY outcome
Timeframe: every 28 days up to 5 yearsPopulation: Due to n=1 and study termination, the data were not analyzed.
Adverse events linked to ascorbate will be categorized and quantified using CTCAE v4 at the bottom of each cycle. Incidence and frequency will be compared to scientific literature
Outcome measures
| Measure |
Gemcitabine With Escalating IV Ascorbate
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)
|
|---|---|
|
Number of Drug-related Adverse Events Per Cycle
|
0
|
SECONDARY outcome
Timeframe: Once every 28 days for up to 5 yearsPopulation: Due to n=1 and study termination, the data were not analyzed.
F2-isoprostane is a marker of systemic oxidative stress.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Once every 28 days up to 5 yearsAscorbate levels will be taken at the bottom of each cycle to assess therapeutic dose window.
Outcome measures
Outcome data not reported
Adverse Events
Gemcitabine With Escalating IV Ascorbate
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gemcitabine With Escalating IV Ascorbate
n=1 participants at risk
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.
Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)
|
|---|---|
|
Investigations
Anemia, grade 1
|
100.0%
1/1 • Number of events 1 • Events collected over one calendar year
Adverse event reporting is consistent with the definition provided by clinicaltrials.gov
|
|
Investigations
white blood cell count, decreased, grade 1
|
100.0%
1/1 • Number of events 1 • Events collected over one calendar year
Adverse event reporting is consistent with the definition provided by clinicaltrials.gov
|
|
Investigations
Lymphocyte count decreased, grade 2
|
100.0%
1/1 • Number of events 1 • Events collected over one calendar year
Adverse event reporting is consistent with the definition provided by clinicaltrials.gov
|
|
Investigations
neutrophil count decreased, grade 3
|
100.0%
1/1 • Number of events 1 • Events collected over one calendar year
Adverse event reporting is consistent with the definition provided by clinicaltrials.gov
|
|
Investigations
platelet count decreased, grade 3
|
100.0%
1/1 • Number of events 1 • Events collected over one calendar year
Adverse event reporting is consistent with the definition provided by clinicaltrials.gov
|
|
Investigations
Alanine aminotransferase increased, grade 1
|
100.0%
1/1 • Number of events 1 • Events collected over one calendar year
Adverse event reporting is consistent with the definition provided by clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place