Clinical trialPhase 1Completed
BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study
BrUOG 278:FOLFOX-A For Pancreatic Cancer :A Brown University Oncology Research Group Study
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- November 2012
- Expected end
- August 2015
- Enrollment
- 35 participants
- Sites
- 3
- Primary outcomes
- Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.
- Sponsor
- Other
- Results posted
- 2016-04-11
- Last update
- 17 February 2020
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer. [For up to 30 days post completing drug, an expected average of 6 months]. Number, participants. Experimental: Dose Level 1 (n=6): 1; Experimental: Dose Level 2/ MTD (n=26): 1; Experimental: Dose Level 3 (n=3): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer. [pre-drug until disease progression, whichever comes first, for an expected average of 6 months]. Number, participants. Experimental: Dose Level 1 (n=6): 3; Experimental: Dose Level 2/ MTD (n=26): 17; Experimental: Dose Level 3 (n=3): 1.