CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
FOLFOXAdrug
Likely dose
FOLFOXA 150mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02578732
NCT02578732Phase 2Completed

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

Brown University·interventional·Posted Oct 19, 2015·Updated May 6, 2023

In Brief

A Phase 2 clinical trial evaluating FOLFOXA for Locally Advanced Pancreatic Cancer and Pancreatic Cancer. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 19, 2015
Enrollment StartJul 12, 2016
Primary CompletionDec 18, 2019
Study CompletionMar 16, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.7 years ago

Interventions

FOLFOXAdrug

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.