Phase II, Neoadjuvant Study of Parasympathetic Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Borderline Resectable Pancreatic Adenocarcinoma
Who is this study for? Patients with borderline resectable pancreatic adenocarcinoma
What treatments are being studied? Bethanechol+Gemcitabine+Nab-paclitaxel
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The primary objective of this study is to assess the impact of bethanechol therapy on R0 resection rates. The safety objective will be assessment of the safety and tolerability of bethanechol in combination with gemcitabine and nab-paclitaxel. The exploratory objective will be to evaluate genomic biomarkers associated with parasympathetic stimulation in pancreatic cancer, and the ability to reduce tumor growth rate.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Pancreatic Ductal Adenocarcinoma
• Plan for neoadjuvant chemotherapy
• Available diagnostic tissue adequate for biomarker analysis
• Ability to tolerate PO meds and comply with study procedures
Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162
Backup
Susan E Bates, MD
seb2227@cumc.columbia.edu
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 37
Treatments
Experimental: Bethanechol
Patients with borderline resectable pancreatic cancer and no contraindication to bethanechol therapy will receive bethanechol on day 1 and continue until 2 days prior to scheduled surgery for a minimum of 2 months.
Related Therapeutic Areas
Sponsors
Leads: Susan E. Bates