Tamoxifen for Well Differentiated Neurodendocrine Tumors and Hormone Receptor Positive Expression

  • STATUS
    Recruiting
  • End date
    Jun 16, 2023
  • participants needed
    15
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 16 August 2021
platelet count
measurable disease
neutrophil count
who 2017
pancreatic net

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).

Details
Condition Neuroendocrine Tumor, Neuroectodermal Tumor, Estrogen Receptor Positive Tumor, Progesterone Receptor Positive Tumor, Neurectoderma, neuroendocrine tumors, neuroendocrine tumour
Treatment Tamoxifen 20 mg
Clinical Study IdentifierNCT04123262
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

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
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