Study of 5-fluorouracil (5-FU), Nab®1-paclitaxel, Bevacizumab, Leucovorin, and Oxaliplatin in Patients With Metastatic Pancreatic Cancer

Conditions

• Metastatic Pancreas Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• 5FU — DRUG
  5 fluorouracil (5-FU) (180 mg/m\^2/day for 14 days) by CIVI via ambulatory pump
• nab-paclitaxel — DRUG
  nab-paclitaxel (75 mg/m\^2) as a 30-minute (min) IV infusion on Days 1, 8, and 15
• bevacizumab — DRUG
  bevacizumab (5 mg/kg) as an IV infusion on Days 1 and 15
• calcium leucovorin — DRUG
  calcium leucovorin (20 mg/m\^2) IV bolus, on Days 1, 8, 15
• oxaliplatin — DRUG
  oxaliplatin (40 mg/m\^2) as a 60-min IV infusion on Days 1, 8, and 15

Study Details

The purpose of this study is to learn about the safety and potential benefit of metronomic 5-fluorouracil in combination with nab®1-paclitaxel, bevacizumab, leucovorin, and oxaliplatin in treating patients with metastatic pancreatic adenocarcinoma.

Key Dates

First listed

Dec 3, 2015

Start date

Jan 18, 2016

Status verified

Oct 2019

Primary completion

Oct 29, 2018

Completion

Oct 29, 2018

Study Design

Enrollment

12 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: FABLOx
  5 fluorouracil (5-FU ) (180 mg/m\^2/day for 14 days), by continuous intravenous infusion (CIVI) via ambulatory pump, nab-paclitaxel (75 mg/m\^2) as a 30-minute (min) IV infusion on Days 1, 8, and 15, bevacizumab (5 mg/kg) as an IV infusion on Days 1 and 15, calcium leucovorin (20 mg/m\^2) IV bolus on Days 1, 8, 15, and oxaliplatin (40 mg/m\^2) as a 60-min IV infusion on Days 1, 8, and 15. First bevacizumab infusion is given over 90 minutes.

Primary Outcome Measure

Dose limiting toxicities (Phase 1) [ Time Frame: Up to Day 1 of Cycle 2 ]

Locations (7)

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