Trial Outcomes & Findings for Ph 2 Trial of Vitamin C & G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan, Oxaliplatin) for Pancreatic Cancer (NCT NCT01905150)
NCT ID: NCT01905150
Last Updated: 2024-12-11
Results Overview
Mean months subjects survived.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Survival was monitored from the first day of treatment until the date of death or last followed up.
Results posted on
2024-12-11
Participant Flow
First subject enrolled: 13-August-2014; Last subject enrolled: 12-June-2017; Last investigational treatment: 21-June-2017.
Once consented, subjects were randomly assigned to one of the two arms, and then screened for eligibility.
Participant milestones
| Measure |
G-FLIP + VitaminC, Then G-FLIP-DM + Vitamin C
G-FLIP in combination with Vitamin C were given. When Disease Progression occurred, G-FLIP-DM + Vitamin C were given.
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
Vitamin C: High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM
|
G-FLIP for 2 Weeks, Then G-FLIP + Vitamin C, Then G-FLIP-DM + Vitamin C
G-FLIP alone without Vitamin C for 2 weeks, then G-FLIP + Vitamin C. In the event of Disease Progression, G-GLIP-DM + Vitamin C were given.
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
18
|
|
Overall Study
COMPLETED
|
12
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
G-FLIP + VitaminC, Then G-FLIP-DM + Vitamin C
G-FLIP in combination with Vitamin C were given. When Disease Progression occurred, G-FLIP-DM + Vitamin C were given.
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
Vitamin C: High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM
|
G-FLIP for 2 Weeks, Then G-FLIP + Vitamin C, Then G-FLIP-DM + Vitamin C
G-FLIP alone without Vitamin C for 2 weeks, then G-FLIP + Vitamin C. In the event of Disease Progression, G-GLIP-DM + Vitamin C were given.
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
|
|---|---|---|
|
Overall Study
Subjects was enrolled but did not start treatment because subjects have poor physical condition.
|
2
|
0
|
Baseline Characteristics
Ph 2 Trial of Vitamin C & G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan, Oxaliplatin) for Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC
n=14 Participants
G-FLIP in combination with Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
Vitamin C: High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM
|
G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.
n=18 Participants
G-FLIP alone for 2 weeks, then G-FLIP + Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C.
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Stage of Disease
Stage III
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Stage of Disease
Stage IV
|
13 participants
n=5 Participants
|
18 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Survival was monitored from the first day of treatment until the date of death or last followed up.Mean months subjects survived.
Outcome measures
| Measure |
G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC
n=14 Participants
G-FLIP in combination with Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
Vitamin C: High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM
|
G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.
n=18 Participants
G-FLIP alone for 2 weeks, then G-FLIP + Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C.
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
|
|---|---|---|
|
Overall Survival
|
9.5 Median months subjects survived
Interval 2.5 to 19.3
|
10.1 Median months subjects survived
Interval 6.0 to 14.1
|
SECONDARY outcome
Timeframe: Performed before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years after the start of treatment.Objective Response as a means of efficacy assessment was evaluated in terms of response rate. The response rate assessments included Complete Responses (CR), Partial Responses (PR), Overall Response Rate (ORR), Stable Disease (SD), and Disease Control Rate (DCR). The response rate was according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. CR was disappearance of all target lesions. PR was \>=30% decrease in the sum of the longest diameter of target lesions. ORR was CR + PR. SD was a condition that was not PR or Progressive Disease (PD). Finally, DCR was ORR + SD.
Outcome measures
| Measure |
G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC
n=14 Participants
G-FLIP in combination with Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
Vitamin C: High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM
|
G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.
n=18 Participants
G-FLIP alone for 2 weeks, then G-FLIP + Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C.
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
|
|---|---|---|
|
Objective Response
CR
|
0.0 Percentage
|
5.6 Percentage
|
|
Objective Response
PR
|
14.3 Percentage
|
33.3 Percentage
|
|
Objective Response
SD
|
57.1 Percentage
|
22.2 Percentage
|
|
Objective Response
ORR
|
14.3 Percentage
|
38.9 Percentage
|
|
Objective Response
DCR
|
71.4 Percentage
|
61.1 Percentage
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Performed before the start of treatment, at the beginning of each 2-week treatment cycle, and at follow-up visit two weeks after completion of treatment.Responses to Quality of Life questionnaire over a year since the start of treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Performed before the start of treatment, at the beginning of each 2-week treatment cycle, and at follow-up visit two weeks after completion of treatment.The incidence of adverse events, as measured by blood tests, signs/symptoms, etc.
Outcome measures
Outcome data not reported
Adverse Events
G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC
Serious events: 0 serious events
Other events: 9 other events
Deaths: 14 deaths
G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.
Serious events: 0 serious events
Other events: 13 other events
Deaths: 18 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC
n=14 participants at risk
G-FLIP in combination with Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
Vitamin C: High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM
|
G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.
n=18 participants at risk
G-FLIP alone for 2 weeks, then G-FLIP + Vitamin C. When Disease Progression occurred, then G-FLIP-DM + Vitamin C.
G-FLIP: G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DM: G-FLIP-DM is low doses of Gemcitabine, Fluorouracil \[5FU\], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
11.1%
2/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
|
Nervous system disorders
Depression
|
14.3%
2/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
5.6%
1/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
5.6%
1/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
|
General disorders
Fatigue
|
14.3%
2/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
11.1%
2/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
|
General disorders
Pain
|
14.3%
2/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
5.6%
1/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
|
General disorders
Insomnia
|
7.1%
1/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
11.1%
2/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
22.2%
4/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
|
General disorders
Anxiety
|
14.3%
2/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
5.6%
1/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
|
Gastrointestinal disorders
Ascites
|
7.1%
1/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
0.00%
0/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
|
Blood and lymphatic system disorders
Anorexia
|
0.00%
0/14 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
11.1%
2/18 • Performed 1-2 weeks before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years.
According to clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place