Trial Outcomes & Findings for FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial (NCT NCT02578732)
NCT ID: NCT02578732
Last Updated: 2023-05-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
From date of start of treatment, until the date of first documented progression, whichever came first, assessed up to 3 years
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
FOLFOXA
Schema:
1 cycle = 14 days \*\*It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG\*\*
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.)
* It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
* Antiemetics will be administered as per standard institutional policy.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Baseline characteristics by cohort
| Measure |
FOLFOXA
n=28 Participants
Schema:
1 cycle = 14 days \*\*It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG\*\*
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.)
* It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
* Antiemetics will be administered as per standard institutional policy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of start of treatment, until the date of first documented progression, whichever came first, assessed up to 3 yearsOutcome measures
| Measure |
FOLFOXA
n=28 Participants
Schema:
1 cycle = 14 days \*\*It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG\*\*
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.)
* It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
* Antiemetics will be administered as per standard institutional policy.
|
|---|---|
|
Response Rate of FOLFOX-A for Patients With Locally Advanced Pancreatic Cancer.
Complete Response
|
0 Participants
|
|
Response Rate of FOLFOX-A for Patients With Locally Advanced Pancreatic Cancer.
Partial Response
|
12 Participants
|
|
Response Rate of FOLFOX-A for Patients With Locally Advanced Pancreatic Cancer.
Stable Disease
|
12 Participants
|
|
Response Rate of FOLFOX-A for Patients With Locally Advanced Pancreatic Cancer.
Progressive Disease
|
4 Participants
|
SECONDARY outcome
Timeframe: During treatment (approximately every 2 weeks for up to 6 months), then approximately every 4 months for for a maximum of 5 yearsOutcome measures
| Measure |
FOLFOXA
n=28 Participants
Schema:
1 cycle = 14 days \*\*It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG\*\*
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.)
* It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
* Antiemetics will be administered as per standard institutional policy.
|
|---|---|
|
Overall Survival for Patients With Locally Advanced Pancreatic Cancer Treated With FOLFOX-A
|
12.3 months
Interval 2.0 to 36.0
|
Adverse Events
FOLFOXA
Serious events: 8 serious events
Other events: 28 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
FOLFOXA
n=28 participants at risk
Schema:
1 cycle = 14 days \*\*It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG\*\*
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.)
* It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
* Antiemetics will be administered as per standard institutional policy.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
2/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
General disorders
Fever
|
7.1%
2/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
1/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Infections and infestations
Infection, other
|
3.6%
1/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Cardiac disorders
Cardiac disorder, other
|
3.6%
1/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
Other adverse events
| Measure |
FOLFOXA
n=28 participants at risk
Schema:
1 cycle = 14 days \*\*It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG\*\*
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.)
* It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
* Antiemetics will be administered as per standard institutional policy.
|
|---|---|
|
Investigations
Neutropenia
|
89.3%
25/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Investigations
Thrombocytopenia
|
60.7%
17/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
64.3%
18/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
89.3%
25/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
20/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
35.7%
10/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
5/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
53.6%
15/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
General disorders
Fatigue
|
89.3%
25/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
17.9%
5/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Investigations
Weight loss
|
67.9%
19/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Investigations
Elevated AST/ALT
|
42.9%
12/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
|
Investigations
Elevated alkaline phosphatase
|
71.4%
20/28 • Deaths were assessed up to 5 years. Adverse events were assessed until 30 days after the last dose of FOLFOX-A, up to 28 weeks
|
Additional Information
Howard Safran, MD
Brown University Oncology Research Group
Phone: 401-863-300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place