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Trial record 7 of 2711 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT03870399
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Rachel Riechelmann, AC Camargo Cancer Center

Brief Summary:
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.

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single-arm, unicentric, single-stage clinical study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Hormone Therapy With Tamoxifen in Patients With Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : March 13, 2022
Estimated Study Completion Date : March 13, 2025

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
The treatment to be used will be tamoxifen 20mg orally once daily.




Primary Outcome Measures :
  1. Disease control rate [ Time Frame: at 24 weeks after initiation of tamoxifen (at the 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. Patients 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


Other Outcome Measures:
  1. PET-CT gallium-68 intake variation [ Time Frame: Through study completion, an average of 3 years ]
    Evaluate possible variations in intensity of intake between PET-CT gallium-68 pre-treatment and 12 weeks after initiation of tamoxifen as a continuous variable for each capture lesion.

  2. PET-CT gallium-68 number variation [ Time Frame: Through study completion, an average of 3 years ]
    Evaluate possible variations in number of sites with intake between PET-CT gallium-68 pre-treatment and 12 weeks after initiation of tamoxifen as a continuous variable for each capture lesion.

  3. CTC positivity rate [ Time Frame: Through study completion, an average of 3 years ]
    Evaluate the percentage of CTC positivity in NET.



Information from the National Library of Medicine

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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:

  • 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.

Exclusion Criteria:

  • 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

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): NCT03870399


Contacts
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Contact: Rachel SP Riechelmann, Phd +55 11 2180-5000 ext 2779 rachel.riechelmann@accamargo.org.br
Contact: Mauro DS Donadio, Dr +55 11 2180-5000 ext 2779 maurodsd@gmail.com

Locations
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Brazil
AC Camargo Cancer Center Recruiting
São Paulo, SP, Brazil, 01525000
Contact: Rachel SP Riechelmann, Phd    +5511 21895000 ext 2779    rachelri2005@gmail.com   
Contact: Mauro DS Donadio, Dr    +5511 21895000 ext 2779    maurodsd@gmail.com   
Sponsors and Collaborators
AC Camargo Cancer Center
Investigators
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Principal Investigator: Rachel SP Riechelmann, Phd Fundacao Antonio Prudente
  Study Documents (Full-Text)

Documents provided by Rachel Riechelmann, AC Camargo Cancer Center:

Publications:

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Responsible Party: Rachel Riechelmann, Head of Clinical Oncology Department, AC Camargo Cancer Center
ClinicalTrials.gov Identifier: NCT03870399     History of Changes
Other Study ID Numbers: 2626/18
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rachel Riechelmann, AC Camargo Cancer Center:
neuroendocrine tumor
tamoxifen
Progesterone Receptor
Estrogen Receptor

Additional relevant MeSH terms:
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Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Hormones
Tamoxifen
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