CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
Dose level 1 +2 moredrug
Likely dose
Dose level 1 125 mg/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/NCT01744353
NCT01744353Phase 1Completed

BrUOG 278:FOLFOX-A For Pancreatic Cancer :A Brown University Oncology Research Group Study

Brown University·interventional·Posted Dec 6, 2012·Updated Feb 17, 2020

In Brief

A Phase 1 clinical trial evaluating Dose level 1, Dose level 2/MTD, and 1 other intervention for Metastatic Pancreatic Cancer. Completed, enrolled 35 participants across 3 sites.

Detailed Summary

The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer. The experimental part of the study is combining these drugs together in FOLFOX-A.

Study Details

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

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2012
Enrollment StartNov 1, 2012
Primary CompletionSep 1, 2014
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.6 years ago

Interventions

Dose level 1drug

Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Dose level 2/MTDdrug

Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Dose level 3drug

Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion