Tamoxifen for Well Differentiated Neurodendocrine Tumors and Hormone Receptor Positive Expression

Neuroendocrine Tumors Clinical Trial

Official title:

HORMONET: Phase II Study of Hormone Therapy With Tamoxifen in Patients With Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04123262
• Other study ID #: MCC-20168
• Status: Recruiting
• Phase: Phase 2
• Start date: November 13, 2019
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Taymeyah Al-Toubah
• Phone: (813) 745-6454
• Email: Taymeyah.Altoubah[@]Moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-arm, single-stage clinical study of tamoxifen for patients with well-differentiated neuroendocrine tumors and radiological progression with positive (> 1%) HR (estrogen and/or progesterone) expression by immunohistochemistry (IHC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological diagnosis of well differentiated NET (typical and atypical lung carcinoids, NET G1, NET G2 of all gastroenteropancreatic sites and pancreatic NET G3 according to WHO 2017 classification) 20 advanced / metastatic, inoperable, with no possibility of curative treatment

• Immunohistochemical expression = 1 percent for estrogen and / or progesterone receptor

• Disease with radiological progression (at least 10 percent tumor volume growth) in the last 12 months before day 1 cycle 1.

• No possibility of established treatments due to lack of access, risk of toxicities or without clinical indication. Patients who meet criteria for watchful waiting (low-dose disease and non-functioning NET) may be included.

• Measurable disease

• ECOG performance scale 0 to 2.

• Adequate organic function as defined by the following criteria:

• serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT) = 2.5 times the upper limit of local laboratory normality (ULN-LL); (up to 5xULN for participants with liver metastases)

• Total serum bilirubin = 2.0 x ULN-LL;

• Absolute neutrophil count = 1,500 / mm^3;

• Platelet count = 80,000 / mm^3;

• Hemoglobin = 9.0 g / dL;

• Estimated creatinine clearance by the MDRD equation = 30ml / min

• Albumin = 3.5 g / dL;

• INR = 1.5

• Term of free and informed consent signed by the patient or legal representative

Exclusion Criteria:

• Participants already on tamoxifen, but other prior treatment are allowed

• Participants with aggressive disease requiring cytotoxic therapy or locoregional therapies (eg hepatic embolization)

• A history of serious clinical or psychiatric illness that, by clinical judgment, may involve participation risk in this study

• Participants participating in other protocols with experimental drugs

• Participants with oral food difficulties

• Participants who underwent major recent surgery less than 4 weeks previously

• Participants receiving chemotherapy or other oncologic therapy for less than 3 weeks

• Participants who use oral anticoagulation

• Previous history of deep vein thrombosis or pulmonary embolism in the last 12 months

• Pregnant or lactating participants

• Participants with postmenopausal vaginal bleeding with no defined etiology

• Participants with breast cancer who need to use tamoxifen for this neoplasm

• Another synchronous neoplasm that requires systemic treatment

Related Conditions & MeSH terms

• Estrogen Receptor Positive Tumor
• Neoplasms
• Neuroendocrine Tumors
• Progesterone Receptor Positive Tumor

Intervention

Drug:
• Tamoxifen 20 mg
Tamoxifen 20mg orally will be given once daily to participants with water

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate	Defined by absence of radiological progression in conventional imaging examinations by RECIST 1.1. Isolated increase of biomarker (chromogranin A) or specific hormone will not be considered progression.	At 24 weeks after start of tamoxifen (at end of cycle 6 - each cycle is 28 days)
Secondary	Progression-free survival	Defined by time from tamoxifen day 1 cycle 1 to death from any cause or radiological progression by RECIST 1.1, whichever occurs first. Participants alive and without progression at the time of study analysis will be censored for time-to-event analysis.	Through study completion, an average of 5 years
Secondary	Rate of Biochemical response	Defined by at least 30 percent drop in the marker (chromogranin and / or specific hormone) at any time of treatment in relation to pre-treatment value	Through study completion, an average of 5 years
Secondary	Radiological response rate	Assessed by RECIST criteria 1.1	Through study completion, an average of 5 years
Secondary	Disease control rate	Defined by absence of radiological progression by RECIST 1.1 criteria, according to the intensity of expression by immunohistochemistry (IHC) of HR and also according to primary site (pancreas, gastrointestinal or lung)	Through study completion, an average of 5 years
Secondary	Incidence of Treatment-related Adverse Events	Frequency of adverse events of grades 2 or more by Common Adverse Event Toxicity Criteria (CTCAE) version 5.0	Through study completion, an average of 5 years