Tamoxifen for Well Differentiated Neurodendocrine Tumors and Hormone Receptor Positive Expression

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Treatments: Hormones; Tamoxifen

Criteria

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