Trial Outcomes & Findings for FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer (NCT NCT01688336)
NCT ID: NCT01688336
Last Updated: 2017-10-06
Results Overview
All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).
TERMINATED
PHASE2
9 participants
Up to 3 years
2017-10-06
Participant Flow
11 patients were consented. One patient was consented but not treated due to metastatic disease and one patient was consented and not treated due to disease progression prior to protocol therapy. 9 patients went on study.
Participant milestones
| Measure |
FOLFIRINOX
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
FOLFIRINOX
n=9 Participants
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
Age, Continuous
|
63.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 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
|
1 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
|
4 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
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Patients with unresectable locally advanced pancreatic cancer.
All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).
Outcome measures
| Measure |
FOLFIRINOX
n=5 Participants
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer
|
28.5 months
Interval 6.2 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 3 yearsAll patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)
Outcome measures
| Measure |
FOLFIRINOX
n=4 Participants
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
Overall Survival for Borderline Resectable Patients
|
9.0 Months
Interval 5.8 to 16.2
|
SECONDARY outcome
Timeframe: the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 yearsProgression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored
Outcome measures
| Measure |
FOLFIRINOX
n=9 Participants
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
Progression Free Survival (PFS)
|
10.7 Months
Interval 2.0 to 24.8
|
SECONDARY outcome
Timeframe: Up to 3 yearsAll patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically.
Outcome measures
| Measure |
FOLFIRINOX
n=9 Participants
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
Objective Response Rate
|
11 percentage of patients
Interval 0.0 to 48.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsDisease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.
Outcome measures
| Measure |
FOLFIRINOX
n=9 Participants
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
Disease Control Rate (DCR)
|
89 percentage of patients
Interval 52.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsRate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.
Outcome measures
| Measure |
FOLFIRINOX
n=9 Participants
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
Rate of Resectability (RR)
|
22 percentage of patients
Interval 0.0 to 60.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPopulation: Data were not collected
Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).
Outcome measures
Outcome data not reported
Adverse Events
FOLFIRINOX
Serious adverse events
| Measure |
FOLFIRINOX
n=9 participants at risk
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
General disorders
Death
|
11.1%
1/9 • 24 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
1/9 • 24 weeks
|
|
Renal and urinary disorders
Renal Calculi
|
11.1%
1/9 • 24 weeks
|
Other adverse events
| Measure |
FOLFIRINOX
n=9 participants at risk
FOLFIRINOX given to all subjects
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
3/9 • 24 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
33.3%
3/9 • 24 weeks
|
|
Investigations
Alkaline Phosphatase Increased
|
66.7%
6/9 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
77.8%
7/9 • 24 weeks
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
1/9 • 24 weeks
|
|
Investigations
Aspartate Aminotransferase Increased
|
33.3%
3/9 • 24 weeks
|
|
Investigations
Blood Bilirubin Increased
|
11.1%
1/9 • 24 weeks
|
|
General disorders
Chills
|
11.1%
1/9 • 24 weeks
|
|
Investigations
Creatinine Increased
|
22.2%
2/9 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
4/9 • 24 weeks
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • 24 weeks
|
|
General disorders
Edema Limbs
|
11.1%
1/9 • 24 weeks
|
|
General disorders
Fatigue
|
44.4%
4/9 • 24 weeks
|
|
General disorders
Fever
|
11.1%
1/9 • 24 weeks
|
|
Investigations
Ggt Increased
|
55.6%
5/9 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
1/9 • 24 weeks
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
55.6%
5/9 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
44.4%
4/9 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
6/9 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
44.4%
4/9 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
55.6%
5/9 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
3/9 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
1/9 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • 24 weeks
|
|
Investigations
Lipase Increased
|
11.1%
1/9 • 24 weeks
|
|
Investigations
Lymphocyte Count Decreased
|
22.2%
2/9 • 24 weeks
|
|
Gastrointestinal disorders
Mucositis Oral
|
22.2%
2/9 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • 24 weeks
|
|
Investigations
Neutrophil Count Decreased
|
88.9%
8/9 • 24 weeks
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
44.4%
4/9 • 24 weeks
|
|
Investigations
Platelet Count Decreased
|
66.7%
6/9 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
11.1%
1/9 • 24 weeks
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
11.1%
1/9 • 24 weeks
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • 24 weeks
|
|
Infections and infestations
Vaginal Infection
|
11.1%
1/9 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • 24 weeks
|
|
Investigations
White Blood Cell Decreased
|
55.6%
5/9 • 24 weeks
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place