Bethanechol before Surgery in Treating Patients with Resectable Pancreatic Cancer

Inclusion Criteria

• Be willing and able to provide written informed consent for the trial.
• Have histologically or cytologically confirmed diagnosis of resectable pancreatic ductal adenocarcinoma or be willing to undergo a biopsy with confirmed pathology prior to starting therapy.
• Have a predicted life expectancy of greater than 3 months.
• Have a performance status of 0 or 1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days of first dose of study drug.
• Have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication (cycle 1, day 1) (female subjects of childbearing potential). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Exclusion Criteria

• Is currently using an acetylcholinesterase inhibitor or a beta-blocker.
• Has active peptic ulcer disease as defined by documented peptic ulcer and symptoms uncontrolled with oral medication.
• Has a known hypersensitivity or allergy to bethanechol.
• Has uncontrolled hyperthyroidism, defined as clinical hyperthyroidism uncontrolled by oral medication.
• Has bradycardia with resting heart rate < 50 beats per minute.
• Has chronic hypotension with resting systolic blood pressure < 90 mmHg.
• Has symptomatic coronary artery disease, such as angina or symptoms of claudication.
• Has vasomotor instability.
• Has a seizure disorder or required anti-seizure medication for seizure prevention within 5 years prior to study entry.
• Has a history of Parkinson’s disease.
• Has bronchial asthma.
• Has a history of recent urinary bladder surgery within 12 months of study entry.
• Has a history of gastrointestinal resection and anastomosis within 12 months of study entry.
• Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
• Due to the possibility of enhanced adverse or toxic effects of cholinergic agonists, subjects who are taking acetylcholinesterase inhibitors or beta-blockers will be excluded from the study.
• Pregnant women are excluded from this study because bethanechol is a Category C agent without adequate and well-controlled studies in humans to assess the impact on reproduction.
• Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with bethanechol, breastfeeding should be discontinued if the mother is treated with bethanechol.