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.
See summary above
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
Rhode Island Hospital and The Miriam Hospital
Providence, Rhode Island, United States
Response Rate of FOLFOX-A for Patients With Locally Advanced Pancreatic Cancer.
Time frame: From date of start of treatment, until the date of first documented progression, whichever came first, assessed up to 3 years
Overall Survival for Patients With Locally Advanced Pancreatic Cancer Treated With FOLFOX-A
Time frame: During treatment (approximately every 2 weeks for up to 6 months), then approximately every 4 months for for a maximum of 5 years
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