RecruitingPhase 2NCT05241249

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

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


Sponsor

Susan E. Bates

Enrollment

37 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding bethanechol — a drug that stimulates nerve signaling in the digestive system — to standard chemotherapy (gemcitabine and nab-paclitaxel) before surgery can help treat pancreatic cancer more effectively. The idea is that nerve signals may fuel tumor growth. **You may be eligible if...** - You have been diagnosed with pancreatic ductal adenocarcinoma (a common type of pancreatic cancer) - You are planning to receive pre-surgery chemotherapy - Your cancer has not spread to distant organs - You can swallow pills and comply with study procedures **You may NOT be eligible if...** - Your cancer has already spread beyond the pancreas - You have bowel obstruction signs - You have a slow heart rate (below 55) or low blood pressure - You have hyperthyroidism, active heart disease, seizures, or stomach ulcers - You are currently taking acetylcholinesterase inhibitor medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBethanechol

Study Drug: Bethanechol (generic), supplied as 50mg oral tablets. Subjects will take 2 tablets (100mg) twice daily. Medication should be taken 1 hour before meals in AM and PM. Medication will be purchased commercially and dispensed at the research pharmacy.

DRUGGemcitabine

Non-experimental. Chemotherapy will be administered on a day 1, 8 and 15 schedule with gemcitabine at a dose of 1000 mg/m2

DRUGnab-paclitaxel

Non-experimental. Chemotherapy will be administered on a day 1, 8 and 15 schedule with nab-paclitaxel dose at 125 mg/m2


Locations(1)

Columbia University Medical Center

New York, New York, United States

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NCT05241249


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