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Tamoxifen for Well Differentiated Neurodendocrine Tumors and Hormone Receptor Positive Expression

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ClinicalTrials.gov Identifier: NCT04123262
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief 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).

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Progesterone Receptor Positive Tumor Estrogen Receptor Positive Tumor Drug: Tamoxifen 20 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HORMONET: Phase II Study of Hormone Therapy With Tamoxifen in Patients With Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Tamoxifen
The participants will receive tamoxifen 20mg orally once daily with a glass of water. Each cycle will be defined for 42 days (6 weeks).
Drug: Tamoxifen 20 mg
Tamoxifen 20mg orally will be given once daily to participants with water




Primary Outcome Measures :
  1. Disease control rate [ Time Frame: At 24 weeks after start of tamoxifen (at end of cycle 6 - each cycle is 28 days) ]
    Defined by absence of radiological progression in conventional imaging examinations by RECIST 1.1. Isolated increase of biomarker (chromogranin A) or specific hormone will not be considered progression.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Through study completion, an average of 5 years ]
    Defined by time from tamoxifen day 1 cycle 1 to death from any cause or radiological progression by RECIST 1.1, whichever occurs first. Participants alive and without progression at the time of study analysis will be censored for time-to-event analysis.

  2. Rate of Biochemical response [ Time Frame: Through study completion, an average of 5 years ]
    Defined by at least 30 percent drop in the marker (chromogranin and / or specific hormone) at any time of treatment in relation to pre-treatment value

  3. Radiological response rate [ Time Frame: Through study completion, an average of 5 years ]
    Assessed by RECIST criteria 1.1

  4. Disease control rate [ Time Frame: Through study completion, an average of 5 years ]
    Defined by absence of radiological progression by RECIST 1.1 criteria, according to the intensity of expression by immunohistochemistry (IHC) of HR and also according to primary site (pancreas, gastrointestinal or lung)

  5. Incidence of Treatment-related Adverse Events [ Time Frame: Through study completion, an average of 5 years ]
    Frequency of adverse events of grades 2 or more by Common Adverse Event Toxicity Criteria (CTCAE) version 5.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123262


Contacts
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Contact: Taymeyah Al-Toubah (813) 745-6454 Taymeyah.Altoubah@Moffitt.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Taymeyah Al-Toubah    813-745-6454    Taymeyah.Altoubah@Moffitt.org   
Contact: Jonathan Strosberg, MD    (813) 745-7257    Jonathan.Strosberg@Moffitt.org   
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Jonathan Strosberg, MD Moffitt Cancer Center

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04123262     History of Changes
Other Study ID Numbers: MCC-20168
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Tamoxifen
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Tamoxifen
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents