Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Susan E. Bates
• Treatments: Bethanechol; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Pancreatic Ductal Adenocarcinoma

• Plan for neoadjuvant chemotherapy

• Available diagnostic tissue adequate for biomarker analysis

• Ability to tolerate PO meds and comply with study procedures

Exclusion Criteria:

• Metastatic disease

• Evidence of GI obstruction

• Baseline bradycardia (HR<55) or hypotension (systolic blood pressure<90)

• Use of acetylcholinesterase inhibitors

• Medical conditions including: hyperthyroidism, active/symptomatic coronary artery disease, seizure disorder, peptic ulcer disease.