Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection

Launched by UNIVERSITY OF NEBRASKA · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether tamoxifen, a medication commonly used for breast cancer, can help prevent the progression of certain types of pancreatic cysts known as mucinous cystic neoplasms (MCNs) in patients who are not having surgery right away. The trial will include up to 15 participants who are at least 19 years old and have been diagnosed with these pre-invasive cysts. To participate, individuals must be willing to take tamoxifen daily for up to 24 weeks and meet specific health criteria, which include not having certain serious conditions or prior treatments that could complicate their participation.

Participants in the trial can expect to take a daily dose of tamoxifen and will be monitored closely for their health and any side effects. It’s important for potential participants to know that women who can become pregnant and men with partners who can become pregnant will need to use two forms of contraception during the study and for three months afterward. This study is currently recruiting, so if you or someone you know has a pancreatic mucinous cystic neoplasm and might be interested, it could be a valuable opportunity to contribute to research that could help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 19 years
• • Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm (MCN), measurable by cross-sectional imaging
• • Surgical resection of the lesion is not planned due to cyst features, patient factors or patient preference
• • Females of reproductive potential and males with partners of reproductive potential must agree to employ two methods contraception throughout the study and for up to 3 months following treatment. Non-child-bearing potential is defined as age 45 years or older and no menses for greater than or equal to 12 months or any age with surgical removal of the uterus and/or both ovaries.
• • Estimated glomerular filtration rate (eGFR) \> 30mL/min/1.73m2
• • Willing and able to provide informed consent to and abide by the protocol
• Exclusion Criteria:
• • Presence of invasive pancreatic adenocarcinoma or high-grade dysplasia
• • Presence of a solid component or mural nodule, main pancreatic duct dilation or abrupt caliber change, obstructive jaundice, lymphadenopathy
• • Current or prior use of tamoxifen or another estrogen antagonist including, but not limited to, clomifene, raloxifene, fulvestrant, anastrazole; subjects who have previously used an estrogen antagonist are eligible provided the last use was at least 5 years prior to enrollment.
• • Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy or other types of hormonal contraceptives including implants and depot injections; levonorgestrel-releasing intrauterine device (IUD) is permitted.
• * Contraindications to tamoxifen include:
• • Pregnancy or nursing
• • Known allergy or hypersensitivity to tamoxifen
• • Cataracts which affect visual acuity (ie. symptomatic)
• • Retinopathy which affects visual acuity (ie. symptomatic)
• • Current warfarin use
• • History of deep vein thrombosis or pulmonary embolism or other condition which, in the opinion of the investigator, may significantly increase the individual's risk of venous thromboembolism
• • History of stroke
• • Known endometrial hyperplasia or personal history of endometrial carcinoma, uterine sarcoma and uterine carcinosarcoma
• • History of intestinal disease or major gastric surgery likely to alter absorption of tamoxifen or inability to swallow oral medications
• • Uncontrolled illness including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina or uncontrolled cardiac arrhythmias, or other conditions which might jeopardize or preclude the ability of the patient to take tamoxifen or the safety of follow-up visits, scans and procedures
• • Elective surgery planned for the study period
• • Participation in another clinical study with an investigational product during the last 28 days
• • Any participant, in the opinion of the investigator, who will not be able to tolerate treatment, or the participant is unsuitable to participate in the study and is unlikely to comply with study procedures, restrictions and requirements