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Clinical Trial 20168

Cancer Type: Gastrointestinal Tumor
Interventions:Tamoxifen ()

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Jonathan Strosberg

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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

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).

Objective

Primary: To evaluate the efficacy of tamoxifen in patients with NETs that are well-differentiated, express HRs (estrogen and/or progesterone receptor), and are progressing. Secondary: (1) to evaluate progression-free survival; (2) to evaluate biochemical response; (3) objective response rate; (4) disease control rate according to HR expression intensity and primary site; (5) toxicities.

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 Protocol

  • 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