This phase I trial tests whether paricalcitol, hydroxychloroquine and losartan work to modify the supportive tissue (stroma) in the pancreas before surgery in patients with pancreatic ductal cancer that can be removed by surgery (resectable) and has not spread to other places in the body (non-metastatic). Paricalcitol is a form of vitamin D that works by blocking a signal in the cancer tumor cells that leads to growth and spreading of the tumor. Hydroxychloroquine is a drug used to treat malaria and rheumatoid arthritis and may also improve the immune system in a way that tumors may be better controlled. Losartan may improve blood flow and allows for better tissue oxygenation. The pancreatic stroma is changed in pancreatic cancer that encourages the growth of pancreatic cancer. Giving paricalcitol, hydroxychloroquine and losartan before surgery may modify the cancer and make it easier to treat.
Additional locations may be listed on ClinicalTrials.gov for NCT05365893.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Fox Chase Cancer CenterStatus: Active
Contact: Sanjay Reddy
Phone: 215-728-4300
PRIMARY OBJECTIVE:
I. To determine the feasibility of treating patients with this regimen in the preoperative setting and the tolerance of this drug combination.
SECONDARY OBJECTIVE:
I. To establish the stroma-modifying regimen of paricalcitol, hydroxychloroquine sulfate (hydroxychloroquine) and losartan (PHL).
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM A: After standard of care neoadjuvant therapy, patients receive paricalcitol intravenously (IV) on Monday, Wednesday, and Friday of every week or orally (PO) once daily (QD), hydroxychloroquine PO twice daily (BID), and losartan PO QD. Treatment continues for 2-8 weeks until surgery in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection on the trial and during follow up.
ARM B: Patients receive no intervention between standard of care neoadjuvant therapy and surgery. Patients undergo CT or MRI and blood sample collection on the trial and during follow up.
After completion of study treatment, patients are followed up at 2-4 weeks and then every 3 months for up to 2 years.
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorSanjay Reddy