Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01744353
Study type Interventional
Source Brown University
Contact
Status Completed
Phase Phase 1
Start date November 2012
Completion date August 2015

See also
  Status Clinical Trial Phase
Recruiting NCT04753879 - Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer. Phase 2
Completed NCT01417000 - Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer Phase 2
Active, not recruiting NCT02975141 - Afatinib and Gemcitabine/Nab-paclitaxel in Metastatic Pancreatic Cancer Phase 1
Active, not recruiting NCT00761345 - Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer Phase 1
Completed NCT00919282 - Gemcitabine (GFF) in Patients With Pancreatic Cancer Phase 2
Completed NCT01088815 - Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas Phase 2
Completed NCT04133155 - Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer
Withdrawn NCT05251038 - Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer Phase 1/Phase 2
Recruiting NCT04612530 - PANFIRE-3 Trial: Assessing Safety and Efficacy of Irreversible Electroporation (IRE) + Nivolumab + CpG for Metastatic Pancreatic Cancer Phase 1
Completed NCT03602885 - EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options N/A
Recruiting NCT05442749 - Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer Phase 2
Recruiting NCT04222413 - Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors Phase 1
Recruiting NCT03721744 - A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer Phase 2/Phase 3
Completed NCT03261947 - A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors Phase 2
Withdrawn NCT06017323 - Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma Phase 1
Terminated NCT01946646 - Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer Phase 1
Completed NCT01523457 - Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer Phase 2
Active, not recruiting NCT00986661 - A Study to Assess PV-10 Chemoablation of Cancer of the Liver Phase 1
Terminated NCT00726037 - A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer Phase 2
Completed NCT00744640 - Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma Phase 1/Phase 2