Trial Outcomes & Findings for Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study (NCT NCT02345460)
NCT ID: NCT02345460
Last Updated: 2018-07-13
Results Overview
Proportion will be estimated using a binomial test.
TERMINATED
PHASE2
1 participants
Up to 12 weeks
2018-07-13
Participant Flow
Participant milestones
| Measure |
Treatment (FOLFIRINOX)
Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Irinotecan Hydrochloride: Given IV
Oxaliplatin: Given IV
Leucovorin Calcium: Given IV
Fluorouracil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study
Baseline characteristics by cohort
| Measure |
Treatment (FOLFIRINOX)
n=1 Participants
Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Irinotecan Hydrochloride: Given IV
Oxaliplatin: Given IV
Leucovorin Calcium: Given IV
Fluorouracil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
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 12 weeksPopulation: Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.
Proportion will be estimated using a binomial test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.
Time from enrollment to the earlier of death or disease progression. Will be estimated with Kaplan Meier curves.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled on study. Outcome data was not analyzed.
Time from enrollment to death from any cause. Will be estimated with Kaplan Meier curves.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after end of treatment or to the day prior to surgeryPopulation: Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.
Toxicity evaluation will be enumeration of all major toxicities, with proportions calculated for each.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.
Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.
Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.
Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.
Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (FOLFIRINOX)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place