NCT02578732

FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

BrUOG 318: FOLFOX-A For Locally Advanced Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to FOLFIRINOX for patients with metastatic pancreatic cancer and appears to be better tolerated with the ability to administer at least 10 cycles of therapy. Investigators therefore will evaluate FOLFOX-A in a phase II study for patient with locally advanced pancreatic cancer.

Detailed description

See summary above

Conditions

• Locally Advanced Pancreatic Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2016-07-12
• Primary completion: 2019-12-18
• Completion: 2022-03-16
• First posted: 2015-10-19
• Last updated: 2023-05-06
• Results posted: 2021-08-13

Locations

1 site across 1 country: United States