Tamoxifen for the Treatment of Hormone Receptor Positive, Well Differentiated Neuroendocrine Tumors, the HORMONET Study

Status: Active

Description

This phase II trial studies how well tamoxifen works in treating patients with hormone receptor positive, well differentiated neuroendocrine tumors. Hormones, like estrogen and progesterone, can encourage tumors to grow. Tamoxifen is a drug that may block / suppress the production of estrogen and progesterone, and therefore lower the amount of hormone in the body.

Eligibility Criteria

Inclusion Criteria

  • Histological diagnosis of well differentiated NET (typical and atypical carcinoids of the lung, NET G1, NET G2 for all gastroenteropancreatic sites and pancreatic NET G3 according to the World Health Organization [WHO] classification) advanced/metastatic, inoperable, with no possibility of curative treatment
  • Immunohistochemistry expression >= 1% for the estrogen and/or progesterone receptor
  • A disease with radiological progression (at least 10% of tumor growth) in the last 12 months before cycle 1 day 1 (C1D1)
  • Progression on somatostatin analog as well as progression/intolerance with additional systemic therapy if somatostatin/receptor positive, and progression/intolerance after at least one systemic line of treatment if somatostatin receptor negative. Pancreatic NET patients must have received at least two lines of systemic therapy regardless of somatostatin receptor expression
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance scale 0 to 2
  • Serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT) =< 2.5 times the upper limit of local laboratory normality (ULN-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 per the Cockcroft-Gault equation >= 30 mL/min or serum creatinine < 1.5 x upper limit of normal (ULN)
  • Albumin >= 3.5 g/dL
  • Institutional normalized ratio (INR) =< 1.5
  • Informed consent form signed by the patient or legal representative

Exclusion Criteria

  • Patients with prior exposure to tamoxifen
  • Patients with an aggressive disease requiring cytotoxic therapy or locoregional therapies (e.g., hepatic embolization)
  • A history of serious clinical or psychiatric illness that, by clinical judgment, may involve risk due to participation in this study
  • Patients participating in other protocols with experimental drugs
  • Patients having difficulties with ingesting food orally
  • Patients who have recently undergone major surgery, less than 4 weeks ago
  • Patients receiving chemotherapy or other oncological therapy within 3 weeks of cycle 1 day 1
  • Patients who use oral anticoagulation
  • Previous history of deep vein thrombosis or pulmonary embolism in the last 12 months
  • Pregnant or lactating patients
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 30 days after the last dose of study medication. Female patients are considered to be of non-reproductive potential if they are either postmenopausal (at least 12 months with no menses without an alternate medical cause), have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion, or have a congenital or acquired condition that prevents childbearing. Appropriate methods of birth control include: abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)
  • Male subjects of childbearing potential and/or who are sexually active with a female of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 30 days after the last dose of study medication. Male subjects are considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition). Appropriate methods of birth control include: abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)
  • Patients with post-menopausal vaginal bleeding with no defined etiology
  • Patients with breast cancer who need to use tamoxifen for this neoplasm
  • Another synchronous neoplasm that demands systemic treatment

Locations & Contacts

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Jonathan Raphael Strosberg
Phone: 813-745-3636

Trial Objectives and Outline

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of tamoxifen citrate (tamoxifen) in patients with neuroendocrine tumors (NETs) that are well-differentiated, express hormone receptors (HRs) (estrogen and/or progesterone receptor), and are progressing.

SECONDARY OBJECTIVES:

I. To evaluate progression-free survival.

II. To evaluate biochemical response.

III. Objective response rate.

IV. Disease control rate according to HR expression intensity and primary site.

V. Toxicities.

OUTLINE:

Patients receive tamoxifen citrate orally (PO) once daily (QD). Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study, patients are followed up every 12 weeks.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Moffitt Cancer Center

Principal Investigator
Jonathan Raphael Strosberg

Trial IDs

Primary ID MCC-20168
Secondary IDs NCI-2019-07097
Clinicaltrials.gov ID NCT04123262