Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Cysts

Pancreatic Cyst

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Diseases

Gastrointestinal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Tamoxifen

Estrogen Receptor Modulators

Pancrelipase

Pancreatin

Estrogen Antagonists

Estrogen Receptor Antagonists

Estrogens

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Tamoxifen 20mg by mouth daily for up to 6 months

Tamoxifen is a nonsteroidal antiestrogen for oral administration.

Tamoxifen 20mg

Peggy Heires, BA

Christina Hoy, DNP

Kelsey Klute, MD

This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic MCN who will not undergo immediate resection. Up to 15 subjects will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks.

This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic MCN who will not undergo immediate resection. Up to 15 subjects will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks. The primary endpoints are feasibility of tamoxifen as chemoprevention in patients with pancreatic MCN and objective response rate as assessed by MRI. This study is intended to inform the design of a subsequent trial formally powered to detect the benefit of tamoxifen in treating pancreatic MCN.

The clinical features of pancreatic MCN support the influence of sex hormones in the pathogenesis of the disease. Anti-hormonal therapy may therefore constitute an effective approach to treatment of MCN and chemoprevention of pancreatic adenocarcinoma. Preliminary analyses from preclinical studies suggest that tamoxifen inhibits proliferation and apoptosis in MCN epithelial cells and fibroblasts. We hypothesize that in humans, treatment with tamoxifen will lead to cyst regression or stabilization and may spare or delay the need for resection.

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

A Pilot Study of Chemoprevention With Tamoxifen in Patients With Pre-Invasive Pancreas Mucinous Cystic Neoplasms Who Will Not Undergo Immediate Resection

Adherence rate, defined as the proportion of subjects who take ≥70% of the prescribed tamoxifen doses with adherence at least 60%, meaning ≥60% of subjects take ≥70% of the prescribed tamoxifen doses

Retention rate, defined as the proportion of subjects who complete imaging and study procedures at the 6-month visit with retention of at least 50%, meaning at least 50% of subjects complete imaging and study procedures at the 6-month visit

The ORR will be estimated based on the proportion of subjects with complete or partial response on MRI/MRCP; partial response is defined by ≥ 20% decrease in maximal cyst diameter.

University of Nebraska

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Cystadenocarcinoma

Cystadenoma

Cystadenoma, Mucinous

Cystadenocarcinoma, Mucinous

Adenocarcinoma

Carcinoma

Adenoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Cancer

Adenocarcinoma of the Appendix

Anti-Infective Agents

Central Nervous System Depressants

Paclitaxel

Albumin-Bound Paclitaxel

Ethanol

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tubulin Modulators

Antimitotic Agents

Anti-Infective Agents, Local

All patients will receive at least one treatment with alcohol and paclitaxel.

Endoscopic ultrasound will be used to locate and assess the pancreatic cyst. The fluid contents will be aspirated using a fine needle and sent for tumor marker analysis and cytology. With the needle maintained in the same position, 99% ethanol will be injected into the cyst. After 3-5 minutes of lavage, the entire volume of fluid will be removed from the cyst. The same volume of paclitaxel minus 1 mL \[3mg/ml diluted in normal saline from original concentration of 6mg/mL\] will be injected and left in the cyst. The needle is then retracted and the procedure completed. Patients will receive oral prophylactic antibiotics for 5 days after the procedure. Clinical follow up with MRI imaging with be done at 6, 12, 18, and 24 months. For those with a persistent cyst at 12 months, a repeat EUS FNI procedure will be done.

Ethanol and Paclitaxel Injection

Brian M Yan, MD, FRCPC

Pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. However, surgery involves significant risks and emerging opinion suggests that not all cysts need to be surgically removed. An alternative therapy would be ideal, in particular for those where surgical risk outweighs the benefits of resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to surgical resection.

Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for treatment in those with per-cancerous, mucinous pancreatic cysts.

Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

Proportion of patients without cysts at 6 months

Degree of cyst epithelial ablation in those undergoing resection

Change of CEA level in those with persistent/recurrent cyst

Proportion of patients without cysts at 12 months

Proportion of patients without cysts at 18 months

Proportion of patients with no cysts at 24 months

University of Western Ontario, Canada

Lawson Health Research Institute

Assistant Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection	NCT06320990	Pancreatic Cyst Pancreatic Muci...	Tamoxifen 20mg	19 Years -	University of Nebraska
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm	NCT01525706	Mucinous Cystic... Mucinous Cystad... Mucinous Cystad... Benign Neoplasm...	Ethanol and Pac...	18 Years - 85 Years	Lawson Health Research Institute
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm	NCT01525706	Mucinous Cystic... Mucinous Cystad... Mucinous Cystad... Benign Neoplasm...	Ethanol and Pac...	18 Years - 85 Years	Lawson Health Research Institute
Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection	NCT06320990	Pancreatic Cyst Pancreatic Muci...	Tamoxifen 20mg	19 Years -	University of Nebraska

Spots Global Cancer Trial Database for pancreatic mucinous cystic neoplasm