Trial Outcomes & Findings for BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial (NCT NCT02080221)
NCT ID: NCT02080221
Last Updated: 2022-08-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Every 3 months for up to 5 years
Results posted on
2022-08-01
Participant Flow
Participant milestones
| Measure |
FOLFOXA
1 cycle = 14 days 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.)
FOLFOXA
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
FOLFOXA
1 cycle = 14 days 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.)
FOLFOXA
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Clinical Progression of Disease
|
1
|
Baseline Characteristics
BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Baseline characteristics by cohort
| Measure |
FOLFOXA
n=50 Participants
1 cycle = 14 days 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.)
FOLFOXA
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=93 Participants
|
|
Age, Continuous
|
66 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Every 3 months for up to 5 yearsOutcome measures
| Measure |
FOLFOXA
n=48 Participants
1 cycle = 14 days 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.)
FOLFOXA
|
|---|---|
|
Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone.
Progression- free survival
|
5 months
Interval 3.0 to 7.0
|
|
Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone.
Overall survival
|
11 months
Interval 8.0 to 14.0
|
SECONDARY outcome
Timeframe: Every 3 months for up to 5 years.Outcome measures
| Measure |
FOLFOXA
n=48 Participants
1 cycle = 14 days 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.)
FOLFOXA
|
|---|---|
|
Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen
Complete response
|
2 Participants
|
|
Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen
Partial response
|
12 Participants
|
|
Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen
Stable disease
|
12 Participants
|
|
Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen
Progressive disease
|
22 Participants
|
Adverse Events
FOLFOXA
Serious events: 10 serious events
Other events: 48 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
FOLFOXA
n=48 participants at risk
1 cycle = 14 days 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.)
FOLFOXA
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.2%
2/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
2/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
2.1%
1/48 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
1/48 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
1/48 • Up to 28 weeks
|
|
Blood and lymphatic system disorders
Hemoptysis
|
2.1%
1/48 • Up to 28 weeks
|
|
Blood and lymphatic system disorders
Acidosis
|
2.1%
1/48 • Up to 28 weeks
|
|
Injury, poisoning and procedural complications
Acute kidney injury
|
4.2%
2/48 • Up to 28 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/48 • Up to 28 weeks
|
|
Infections and infestations
Infection
|
10.4%
5/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/48 • Up to 28 weeks
|
|
Nervous system disorders
Lethargy
|
2.1%
1/48 • Up to 28 weeks
|
|
General disorders
Multi organ failure
|
2.1%
1/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Duodenal perforation
|
2.1%
1/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
8.3%
4/48 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
2.1%
1/48 • Up to 28 weeks
|
|
General disorders
Edema limbs
|
2.1%
1/48 • Up to 28 weeks
|
|
General disorders
Fatigue
|
2.1%
1/48 • Up to 28 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified
|
2.1%
1/48 • Up to 28 weeks
|
|
General disorders
Pain
|
8.3%
4/48 • Up to 28 weeks
|
|
Infections and infestations
Peritonitis
|
2.1%
1/48 • Up to 28 weeks
|
|
Investigations
Thrombocytopenia
|
4.2%
2/48 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Small bowel obstruction
|
2.1%
1/48 • Up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
3/48 • Up to 28 weeks
|
|
Nervous system disorders
Stroke
|
2.1%
1/48 • Up to 28 weeks
|
|
Vascular disorders
Thromboembolic event
|
4.2%
2/48 • Up to 28 weeks
|
|
Investigations
Blood bilirubin elevated
|
2.1%
1/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
5/48 • Up to 28 weeks
|
|
Infections and infestations
Sepsis
|
4.2%
2/48 • Up to 28 weeks
|
Other adverse events
| Measure |
FOLFOXA
n=48 participants at risk
1 cycle = 14 days 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.)
FOLFOXA
|
|---|---|
|
Investigations
Neutropenia
|
43.8%
21/48 • Up to 28 weeks
|
|
Investigations
Thrombocytopenia
|
75.0%
36/48 • Up to 28 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
62.5%
30/48 • Up to 28 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
68.8%
33/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
20/48 • Up to 28 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
27.1%
13/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
12/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
43.8%
21/48 • Up to 28 weeks
|
|
General disorders
Fatigue
|
75.0%
36/48 • Up to 28 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
6/48 • Up to 28 weeks
|
|
Nervous system disorders
Arthralgia
|
4.2%
2/48 • Up to 28 weeks
|
|
Investigations
Weight loss
|
62.5%
30/48 • Up to 28 weeks
|
|
Investigations
Elevated AST/ALT
|
45.8%
22/48 • Up to 28 weeks
|
|
Investigations
Elevated alkaline phosphatase
|
77.1%
37/48 • Up to 28 weeks
|
Additional Information
Howard Safran, MD
Brown University Oncology Research Group
Phone: 4018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place