Study of Tamoxifen in Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression

Completed · Phase 2

Conditions studied: Neuroendocrine Tumors, Progesterone Receptor Positive Tumor, Estrogen Receptor Positive Tumor

In brief

This is a single-arm, unicentric, single-stage clinical study of tamoxifen for patients with well differentiated neuroendocrine tumors and radiological progression with positive (\> 1 percent) HR (estrogen and / or progesterone) expression by IHC. It will evaluate if Tamoxifen exerts antitumor action in patients with well differentiated NET and positive for the expression of HR, estrogen and / or progesterone.

Key facts

Study ID

NCT03870399

Run by

AC Camargo Cancer Center

People needed

23

Starts

2019-03-13

Expected to finish

2023-05-13

Last updated by the study team

2024-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 18 years
• 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 (LSN-LL);
• 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.

You may not qualify if…

• Patients already on tamoxifen, but other prior treatment are allowed
• Patients 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
• Patients participating in other protocols with experimental drugs.
• Patients with oral food difficulties.
• Patients who underwent major recent surgery less than 4 weeks previously.
• Patients receiving chemotherapy or other oncologic therapy for less than 3 weeks.
• Patients who use oral anticoagulation
• Previous history of deep vein thrombosis or pulmonary embolism in the last 12 months.
• Pregnant or lactating patients.
• Patients with postmenopausal vaginal bleeding with no defined etiology.
• Patients with breast cancer who need to use tamoxifen for this neoplasm
• Another synchronous neoplasm that requires systemic treatment

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• AC Camargo Cancer Center — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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