Trial Outcomes & Findings for BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial (NCT NCT02022033)
NCT ID: NCT02022033
Last Updated: 2022-06-01
Results Overview
Determination of the feasibility of administration of adjuvant FOLFOX-A in patients who have undergone resection of pancreatic cancer.Successful administration of FOLFOX-A will be defined as the ability to receive ≥8 cycles of FOLFOX-A.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2022-06-01
Participant Flow
Participant milestones
| Measure |
FOLFOXA
Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
FOLFOXA
Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Baseline characteristics by cohort
| Measure |
FOLFOXA
n=25 Participants
Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 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
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksDetermination of the feasibility of administration of adjuvant FOLFOX-A in patients who have undergone resection of pancreatic cancer.Successful administration of FOLFOX-A will be defined as the ability to receive ≥8 cycles of FOLFOX-A.
Outcome measures
| Measure |
FOLFOXA
n=24 Participants
Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
|
|---|---|
|
Feasibility of Adjuvant FOLFOX-A
|
18 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 years.To evaluate the disease-free survival for patients with resected pancreatic cancer treated with adjuvant FOLFOX-A.
Outcome measures
| Measure |
FOLFOXA
n=24 Participants
Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
|
|---|---|
|
Disease-free Survival
6 months after completion of drug
|
23 Participants
|
|
Disease-free Survival
12 months after completion of drug
|
15 Participants
|
|
Disease-free Survival
24 months after completion of drug
|
12 Participants
|
|
Disease-free Survival
36 months after completion of drug
|
8 Participants
|
Adverse Events
FOLFOXA
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOLFOXA
n=25 participants at risk
Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
|
|---|---|
|
General disorders
Pain
|
4.0%
1/25 • Number of events 1 • Up to 28 weeks
|
Other adverse events
| Measure |
FOLFOXA
n=25 participants at risk
Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
|
|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.0%
3/25 • Up to 28 weeks
|
|
Investigations
Alkaline phosphatase increased
|
60.0%
15/25 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.0%
4/25 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.0%
1/25 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
56.0%
14/25 • Up to 28 weeks
|
|
Investigations
Alanine aminotransferase increased
|
36.0%
9/25 • Up to 28 weeks
|
|
Nervous system disorders
Amnesia
|
4.0%
1/25 • Up to 28 weeks
|
|
Investigations
Neutrophil count decreased
|
52.0%
13/25 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
24.0%
6/25 • Up to 28 weeks
|
|
Psychiatric disorders
Anxiety
|
8.0%
2/25 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
4/25 • Up to 28 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
36.0%
9/25 • Up to 28 weeks
|
|
Gastrointestinal disorders
Bloating
|
8.0%
2/25 • Up to 28 weeks
|
|
Eye disorders
Blurred vision
|
4.0%
1/25 • Up to 28 weeks
|
|
General disorders
Chills
|
12.0%
3/25 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
4.0%
1/25 • Up to 28 weeks
|
|
Infections and infestations
Conjunctivitis
|
4.0%
1/25 • Up to 28 weeks
|
|
Gastrointestinal disorders
Constipation
|
20.0%
5/25 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
3/25 • Up to 28 weeks
|
|
Investigations
Creatinine increased
|
4.0%
1/25 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
5/25 • Up to 28 weeks
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • Up to 28 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
10/25 • Up to 28 weeks
|
|
Nervous system disorders
Dizziness
|
16.0%
4/25 • Up to 28 weeks
|
|
Nervous system disorders
Dysgeusia
|
20.0%
5/25 • Up to 28 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Up to 28 weeks
|
|
General disorders
Edema
|
16.0%
4/25 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
2/25 • Up to 28 weeks
|
|
General disorders
Fatigue
|
72.0%
18/25 • Up to 28 weeks
|
|
Gastrointestinal disorders
Flatulence
|
16.0%
4/25 • Up to 28 weeks
|
|
General disorders
Gait disturbance
|
4.0%
1/25 • Up to 28 weeks
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
1/25 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.0%
2/25 • Up to 28 weeks
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Up to 28 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
56.0%
14/25 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.0%
2/25 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.0%
2/25 • Up to 28 weeks
|
|
Vascular disorders
Hypertension
|
48.0%
12/25 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.0%
1/25 • Up to 28 weeks
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Up to 28 weeks
|
|
Infections and infestations
Infections and infestations
|
32.0%
8/25 • Up to 28 weeks
|
|
Psychiatric disorders
Insomnia
|
24.0%
6/25 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
56.0%
14/25 • Up to 28 weeks
|
|
Investigations
Lymphocyte count decreased
|
32.0%
8/25 • Up to 28 weeks
|
|
Gastrointestinal disorders
Mucositis
|
36.0%
9/25 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective tissue disorder
|
4.0%
1/25 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.0%
7/25 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.0%
4/25 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
12.0%
3/25 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
4.0%
1/25 • Up to 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
64.0%
16/25 • Up to 28 weeks
|
|
General disorders
Pain
|
36.0%
9/25 • Up to 28 weeks
|
|
Investigations
Platelet count decreased
|
40.0%
10/25 • Up to 28 weeks
|
|
Nervous system disorders
Presyncope
|
4.0%
1/25 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.0%
4/25 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
1/25 • Up to 28 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
84.0%
21/25 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
4.0%
1/25 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
4.0%
1/25 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.0%
2/25 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
4.0%
1/25 • Up to 28 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
4.0%
1/25 • Up to 28 weeks
|
|
Renal and urinary disorders
Urinary urgency
|
8.0%
2/25 • Up to 28 weeks
|
|
Gastrointestinal disorders
Vomitting
|
32.0%
8/25 • Up to 28 weeks
|
|
Investigations
White blood cell decreased
|
40.0%
10/25 • Up to 28 weeks
|
|
Investigations
Weight loss
|
56.0%
14/25 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Wound complication
|
4.0%
1/25 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.0%
1/25 • Up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.0%
2/25 • Up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
1/25 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
1/25 • Up to 28 weeks
|
|
General disorders
Flu like symptoms
|
4.0%
1/25 • Up to 28 weeks
|
Additional Information
Howard Safran, MD
Brown University Oncology Research Group
Phone: 401-863-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place