Bethanechol + Chemotherapy for Pancreatic Cancer

Overseen By Susan E Bates, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Susan E. Bates

Must not be taking: Acetylcholinesterase inhibitors

Disqualifiers: Metastatic disease, GI obstruction, bradycardia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

37 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bethanechol in combination with gemcitabine and nab-paclitaxel for a minimum of 2 months

8 weeks

Surgery

Participants undergo surgery after treatment with bethanechol and chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery

36 months

Treatment Details

Interventions

• Bethanechol
• Gemcitabine
• Nab-paclitaxel

Trial Overview The 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

Group I: Bethanechol Experimental Treatment 3 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 European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

Susan E. Bates

Lead Sponsor

Trials

2

Recruited

70+