Trial Outcomes & Findings for A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma (NCT NCT01839799)
NCT ID: NCT01839799
Last Updated: 2021-02-25
Results Overview
In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
20 months
Results posted on
2021-02-25
Participant Flow
Participant milestones
| Measure |
FOLFIRINOX
FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Chemoradiation
|
Gemcitabine/Abraxane
Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15
Chemoradiation
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
FOLFIRINOX
n=17 Participants
FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Chemoradiation
|
Gemcitabine
n=15 Participants
Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15
Chemoradiation
|
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
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 monthsIn this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.
Outcome measures
| Measure |
Arm 1
n=17 Participants
FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Chemoradiation
|
Arm 2
n=15 Participants
Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15
Chemoradiation
|
|---|---|---|
|
Number of Participants With Relapse-free Survival
|
3 Participants
|
2 Participants
|
Adverse Events
Arm 1
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Arm 2
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=17 participants at risk
FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Chemoradiation
|
Arm 2
n=15 participants at risk
Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15
Chemoradiation
|
|---|---|---|
|
Infections and infestations
Viral Syndrome
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
General disorders
Fever
|
23.5%
4/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Gastrointestinal disorders
anemia
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
GI Bleed
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
Gastric Ulcer
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Infections and infestations
hepatic infection (SAE)
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
General disorders
Non-neutropenic fever
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Metabolism and nutrition disorders
increased abd distention
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
11.8%
2/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Infections and infestations
Bacteremia-E.Coli
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
3/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
3/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.9%
1/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
General disorders
Chills
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Investigations
decrease wbc
|
11.8%
2/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
decreased neutrophils
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Metabolism and nutrition disorders
protein malnutrition
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Metabolism and nutrition disorders
decreased appetite
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Infections and infestations
CMV
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
Septic Shock
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bilatteral Hip Pain
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
General disorders
Fever /+ blood culture
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Gastrointestinal disorders
SmBowel Obstruction
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Nervous system disorders
PRESS
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
Other adverse events
| Measure |
Arm 1
n=17 participants at risk
FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Chemoradiation
|
Arm 2
n=15 participants at risk
Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15
Chemoradiation
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
76.5%
13/17 • 2 years
|
33.3%
5/15 • 2 years
|
|
General disorders
fatigue
|
82.4%
14/17 • 2 years
|
86.7%
13/15 • 2 years
|
|
Blood and lymphatic system disorders
anemia
|
11.8%
2/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
diarrhea
|
82.4%
14/17 • 2 years
|
46.7%
7/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
rash
|
17.6%
3/17 • 2 years
|
26.7%
4/15 • 2 years
|
|
Investigations
elevated ALK Phos
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Metabolism and nutrition disorders
anorexia
|
17.6%
3/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Investigations
elevated creatinine
|
0.00%
0/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
elevated trigylcerides
|
0.00%
0/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
thrombocytopenia
|
5.9%
1/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Investigations
elevated ALT
|
0.00%
0/17 • 2 years
|
26.7%
4/15 • 2 years
|
|
Nervous system disorders
headache
|
5.9%
1/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Investigations
hyperkalemia
|
0.00%
0/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
mucositis
|
35.3%
6/17 • 2 years
|
13.3%
2/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
dry skin
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
vomiting
|
58.8%
10/17 • 2 years
|
20.0%
3/15 • 2 years
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Nervous system disorders
dysgeusia
|
11.8%
2/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
General disorders
edema
|
0.00%
0/17 • 2 years
|
40.0%
6/15 • 2 years
|
|
Investigations
elevated cholesterol
|
0.00%
0/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
hypoalbuminemia
|
11.8%
2/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
pruritis
|
0.00%
0/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
weight loss
|
17.6%
3/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Eye disorders
blurred vision
|
0.00%
0/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
constipation
|
23.5%
4/17 • 2 years
|
20.0%
3/15 • 2 years
|
|
Investigations
hyperglycemia
|
23.5%
4/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
hypokalemia
|
29.4%
5/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Investigations
hyponatremia
|
0.00%
0/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
neutropenia
|
58.8%
10/17 • 2 years
|
66.7%
10/15 • 2 years
|
|
Investigations
decreased wbc
|
29.4%
5/17 • 2 years
|
26.7%
4/15 • 2 years
|
|
Investigations
hypomagnesium
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Metabolism and nutrition disorders
dehydration
|
35.3%
6/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
skin infection port
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Musculoskeletal and connective tissue disorders
abd/cramping/pain
|
5.9%
1/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
hiccoughs
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Nervous system disorders
peripheral neuropathy
|
11.8%
2/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
General disorders
Dizziness
|
11.8%
2/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
Decreased Platlets
|
17.6%
3/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Ear and labyrinth disorders
Ear Bleed -L-ear
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
increased Ast
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
decreased plt
|
17.6%
3/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Investigations
hypotension
|
11.8%
2/17 • 2 years
|
13.3%
2/15 • 2 years
|
|
Psychiatric disorders
Insomnia
|
17.6%
3/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Nervous system disorders
neuropathy
|
41.2%
7/17 • 2 years
|
26.7%
4/15 • 2 years
|
|
Gastrointestinal disorders
loose stools/intermittent
|
5.9%
1/17 • 2 years
|
13.3%
2/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
Runny nose
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
Mouth Sores
|
35.3%
6/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
General disorders
fever
|
29.4%
5/17 • 2 years
|
26.7%
4/15 • 2 years
|
|
General disorders
gout
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
decreased neutrophils
|
17.6%
3/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
protein malnutrition
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
decrease wbc
|
5.9%
1/17 • 2 years
|
26.7%
4/15 • 2 years
|
|
General disorders
Lightheadeness
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Renal and urinary disorders
UTI
|
17.6%
3/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.8%
2/17 • 2 years
|
40.0%
6/15 • 2 years
|
|
Psychiatric disorders
Anxiety
|
11.8%
2/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Psychiatric disorders
Depression
|
11.8%
2/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Eye disorders
Myalgia
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Investigations
Decreased Appetite
|
11.8%
2/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Gastrointestinal disorders
Loose bowel movement
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
gas
|
29.4%
5/17 • 2 years
|
40.0%
6/15 • 2 years
|
|
Musculoskeletal and connective tissue disorders
abdominal pain
|
29.4%
5/17 • 2 years
|
20.0%
3/15 • 2 years
|
|
General disorders
night sweats
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Gastrointestinal disorders
flatulance
|
5.9%
1/17 • 2 years
|
26.7%
4/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
ratiation dermatitis
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
hypersensitivity reaction
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Musculoskeletal and connective tissue disorders
abdominal cramping
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Thick feeling tongue
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Infections and infestations
paronychia
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
General disorders
Cold Sensitivity
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Eye disorders
Tunnel Vision
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest Pressure/Spasm
|
5.9%
1/17 • 2 years
|
0.00%
0/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
Soft nails
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
folliculitis
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Nervous system disorders
siatica
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
Gastrointestinal disorders
stomach virus
|
0.00%
0/17 • 2 years
|
13.3%
2/15 • 2 years
|
|
Investigations
elevated AST
|
0.00%
0/17 • 2 years
|
40.0%
6/15 • 2 years
|
|
Metabolism and nutrition disorders
malabsorption
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
General disorders
orthostatic
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/17 • 2 years
|
20.0%
3/15 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Horseness
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
General disorders
Chills
|
0.00%
0/17 • 2 years
|
6.7%
1/15 • 2 years
|
|
General disorders
Fever Other
|
0.00%
0/17 • 2 years
|
20.0%
3/15 • 2 years
|
Additional Information
Jennifer Louie, Program Manager
University of Pennsylvania
Phone: 215-220-9668
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place