Study of 5-fluorouracil (5-FU), Nab®1-paclitaxel, Bevacizumab, Leucovorin, and Oxaliplatin in Patients With Metastatic Pancreatic Cancer
NCT02620800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2019-10-22
Summary
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.
Conditions
- Metastatic Pancreas Adenocarcinoma
Interventions
- DRUG
-
5FU
5 fluorouracil (5-FU) (180 mg/m\^2/day for 14 days) by CIVI via ambulatory pump
- DRUG
-
nab-paclitaxel (75 mg/m\^2) as a 30-minute (min) IV infusion on Days 1, 8, and 15
- DRUG
-
bevacizumab (5 mg/kg) as an IV infusion on Days 1 and 15
- DRUG
-
calcium leucovorin
calcium leucovorin (20 mg/m\^2) IV bolus, on Days 1, 8, 15
- DRUG
-
oxaliplatin (40 mg/m\^2) as a 60-min IV infusion on Days 1, 8, and 15
Sponsors & Collaborators
-
Celgene
lead INDUSTRY
Principal Investigators
-
Chrystal Louis, MD · Celgene
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-18
- Primary Completion
- 2018-10-29
- Completion
- 2018-10-29
Countries
- United States
Study Locations
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