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Tamoxifen for Well Differentiated Neurodendocrine Tumors and Hormone Receptor Positive Expression

Primary Purpose

Neuroendocrine Tumors, Progesterone Receptor Positive Tumor, Estrogen Receptor Positive Tumor

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tamoxifen 20 mg
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Tamoxifen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (ULN-LL); (up to 5xULN for participants with liver metastases)
    • 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

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tamoxifen

Arm Description

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

Outcomes

Primary Outcome Measures

Disease control rate
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

Progression-free survival
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.
Rate of Biochemical response
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
Radiological response rate
Assessed by RECIST criteria 1.1
Disease control rate
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)
Incidence of Treatment-related Adverse Events
Frequency of adverse events of grades 2 or more by Common Adverse Event Toxicity Criteria (CTCAE) version 5.0

Full Information

First Posted
October 9, 2019
Last Updated
October 6, 2022
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04123262
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors, Progesterone Receptor Positive Tumor, Estrogen Receptor Positive Tumor
Keywords
Tamoxifen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamoxifen
Arm Type
Experimental
Arm Description
The participants will receive tamoxifen 20mg orally once daily with a glass of water. Each cycle will be defined for 42 days (6 weeks).
Intervention Type
Drug
Intervention Name(s)
Tamoxifen 20 mg
Intervention Description
Tamoxifen 20mg orally will be given once daily to participants with water
Primary Outcome Measure Information:
Title
Disease control rate
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.
Time Frame
At 24 weeks after start of tamoxifen (at end of cycle 6 - each cycle is 28 days)
Secondary Outcome Measure Information:
Title
Progression-free survival
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.
Time Frame
Through study completion, an average of 5 years
Title
Rate of Biochemical response
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
Time Frame
Through study completion, an average of 5 years
Title
Radiological response rate
Description
Assessed by RECIST criteria 1.1
Time Frame
Through study completion, an average of 5 years
Title
Disease control rate
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)
Time Frame
Through study completion, an average of 5 years
Title
Incidence of Treatment-related Adverse Events
Description
Frequency of adverse events of grades 2 or more by Common Adverse Event Toxicity Criteria (CTCAE) version 5.0
Time Frame
Through study completion, an average of 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 (ULN-LL); (up to 5xULN for participants with liver metastases) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taymeyah Al-Toubah
Phone
(813) 745-6454
Email
Taymeyah.Altoubah@Moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Strosberg, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taymeyah Al-Toubah
Phone
813-745-6454
Email
Taymeyah.Altoubah@Moffitt.org
First Name & Middle Initial & Last Name & Degree
Jonathan Strosberg, MD
Phone
(813) 745-7257
Email
Jonathan.Strosberg@Moffitt.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Tamoxifen for Well Differentiated Neurodendocrine Tumors and Hormone Receptor Positive Expression

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