Clinical Trials /

Tamoxifen for Well Differentiated Neurodendocrine Tumors and Hormone Receptor Positive Expression

NCT04123262

Description:

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).

Related Conditions:
  • Neuroendocrine Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Tamoxifen for Well Differentiated Neurodendocrine Tumors and Hormone Receptor Positive Expression
  • Official Title: HORMONET: Phase II Study of Hormone Therapy With Tamoxifen in Patients With Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression

Clinical Trial IDs

  • ORG STUDY ID: MCC-20168
  • NCT ID: NCT04123262

Conditions

  • Neuroendocrine Tumors
  • Progesterone Receptor Positive Tumor
  • Estrogen Receptor Positive Tumor

Interventions

DrugSynonymsArms
Tamoxifen 20 mgTamoxifen

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
TamoxifenExperimentalThe participants will receive tamoxifen 20mg orally once daily with a glass of water. Each cycle will be defined for 42 days (6 weeks).
  • Tamoxifen 20 mg

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease control rate
Time Frame:At 24 weeks after start of tamoxifen (at end of cycle 6 - each cycle is 28 days)
Safety Issue:
Description: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

Measure:Progression-free survival
Time Frame:Through study completion, an average of 5 years
Safety Issue:
Description: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.
Measure:Rate of Biochemical response
Time Frame:Through study completion, an average of 5 years
Safety Issue:
Description: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
Measure:Radiological response rate
Time Frame:Through study completion, an average of 5 years
Safety Issue:
Description:Assessed by RECIST criteria 1.1
Measure:Disease control rate
Time Frame:Through study completion, an average of 5 years
Safety Issue:
Description: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)
Measure:Incidence of Treatment-related Adverse Events
Time Frame:Through study completion, an average of 5 years
Safety Issue:
Description:Frequency of adverse events of grades 2 or more by Common Adverse Event Toxicity Criteria (CTCAE) version 5.0

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • Tamoxifen

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