RECRUITING

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

Description

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.

Conditions

Study Overview

Study Details

Study overview

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 II, Neoadjuvant Study of Parasympathetic Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Borderline Resectable Pancreatic Adenocarcinoma

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

Condition
Pancreas Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Susan E. Bates,

Susan E Bates, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2025-01