Bethanechol + Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen bySusan E Bates, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Susan E. Bates

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Susan E Bates, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for individuals with Pancreatic Ductal Adenocarcinoma who are planning to undergo neoadjuvant chemotherapy. They must have tissue available for biomarker analysis and be able to take oral medications. People with metastatic disease, GI obstruction, very low heart rate or blood pressure, or certain medical conditions like hyperthyroidism cannot participate.

Inclusion Criteria

I am scheduled for chemotherapy before surgery.

I can take pills and follow study rules.

I have been diagnosed with pancreatic cancer.

See 1 more

Exclusion Criteria

I have a blockage in my digestive tract.

You have a slow heart rate (less than 55 beats per minute) or low blood pressure (less than 90 for the top number).

I do not have hyperthyroidism, active heart disease, seizures, or stomach ulcers.

See 2 more

Treatment Details

Interventions

Bethanechol (Cholinergic Agonist)
Gemcitabine (Anti-metabolite)
Nab-paclitaxel (Anti-tumor antibiotic)

Trial OverviewThe study tests the effect of bethanechol combined with gemcitabine and nab-paclitaxel on pancreatic cancer surgery success rates (R0 resection). It also looks at safety and explores how this treatment might affect tumor growth and genomic markers related to parasympathetic stimulation.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: BethanecholExperimental Treatment3 Interventions

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.

Gemcitabine is already approved in Canada, Japan for the following indications: