search
Back to results

Letrozole in Uterine Leiomyosarcoma

Primary Purpose

Uterine Leiomyosarcoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Letrozole
Sponsored by
GOG Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Leiomyosarcoma

Eligibility Criteria

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

Inclusion Criteria: Patient must have histologically confirmed uterine leiomyosarcoma with disease limited to the uterus (FIGO stage 1 or 2). Tumors must express ER positivity by immunohistochemistry (ER expression greater than or equal to 10% by immunohistochemistry). Must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from initiation of therapy All patients must have no measurable disease within 6 weeks of initiation of therapy. Measurable disease is defined by RECIST version 1.1. Patient must be able to swallow oral medications. Patient must have an ECOG performance status of 0 to 2. Patients must have adequate organ and marrow function as defined below NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1500/mcl Platelets greater than or equal to 100,000 cells/mcl Hemoglobin greater than or equal to 8 g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after erythrocyte transfusion). Renal function: Creatinine less than or equal to 1.5 x ULN Hepatic function: Bilirubin less than or equal to 1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2 times ULN and direct bilirubin within normal limits are permitted). ALT (alanine aminotransferase) and AST (aspartate aminotransferase) less than or equal to 3 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN Albumin greater than or equal to 2.8 g/dL Patients must have signed an approved informed consent and authorization permitting release of personal health information. Patients must be at least 18 years of age. Exclusion Criteria: Patients who have a history of taking any aromatase inhibitor. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors). Patients with active or uncontrolled systemic infection Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past two years. Patients are also excluded if their previous cancer treatment contraindicates this protocol. Patients who are pregnant or breast-feeding. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days prior to dosing. Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases. Patients with history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with an ejection fraction under 40%. Patients currently receiving chemotherapy or radiation therapy. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication Patients deemed otherwise clinically unfit for clinical trial per investigators discretion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Letrozole

    Observation

    Arm Description

    Letrozole 2.5 mg orally

    Observation

    Outcomes

    Primary Outcome Measures

    Progression Free Survival

    Secondary Outcome Measures

    Overall Survival

    Full Information

    First Posted
    December 6, 2022
    Last Updated
    December 6, 2022
    Sponsor
    GOG Foundation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05649956
    Brief Title
    Letrozole in Uterine Leiomyosarcoma
    Official Title
    A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 30, 2023 (Anticipated)
    Primary Completion Date
    October 30, 2027 (Anticipated)
    Study Completion Date
    October 30, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GOG Foundation

    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.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients. Patients will receive 2/5 mg of letrozole daily.
    Detailed Description
    This is a randomized phase II study of letrozole (Femara) administered 2.5 mg orally daily to patients with newly diagnosed clinical stage I and II LMS. Using an adaptive randomization, patients will be assigned to either the treatment arm (letrozole group) or observation. The primary outcome for this trial is the time to progression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uterine Leiomyosarcoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Letrozole
    Arm Type
    Experimental
    Arm Description
    Letrozole 2.5 mg orally
    Arm Title
    Observation
    Arm Type
    No Intervention
    Arm Description
    Observation
    Intervention Type
    Drug
    Intervention Name(s)
    Letrozole
    Intervention Description
    Letrozole 2.5 mg PO daily
    Primary Outcome Measure Information:
    Title
    Progression Free Survival
    Time Frame
    Measured from time of enrollment until date of progression or death up 3 years from randomization
    Secondary Outcome Measure Information:
    Title
    Overall Survival
    Time Frame
    Measured for time of enrollment to time of death assessed up to 5 years from randomization

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient must have histologically confirmed uterine leiomyosarcoma with disease limited to the uterus (FIGO stage 1 or 2). Tumors must express ER positivity by immunohistochemistry (ER expression greater than or equal to 10% by immunohistochemistry). Must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from initiation of therapy All patients must have no measurable disease within 6 weeks of initiation of therapy. Measurable disease is defined by RECIST version 1.1. Patient must be able to swallow oral medications. Patient must have an ECOG performance status of 0 to 2. Patients must have adequate organ and marrow function as defined below NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1500/mcl Platelets greater than or equal to 100,000 cells/mcl Hemoglobin greater than or equal to 8 g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after erythrocyte transfusion). Renal function: Creatinine less than or equal to 1.5 x ULN Hepatic function: Bilirubin less than or equal to 1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2 times ULN and direct bilirubin within normal limits are permitted). ALT (alanine aminotransferase) and AST (aspartate aminotransferase) less than or equal to 3 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN Albumin greater than or equal to 2.8 g/dL Patients must have signed an approved informed consent and authorization permitting release of personal health information. Patients must be at least 18 years of age. Exclusion Criteria: Patients who have a history of taking any aromatase inhibitor. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors). Patients with active or uncontrolled systemic infection Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past two years. Patients are also excluded if their previous cancer treatment contraindicates this protocol. Patients who are pregnant or breast-feeding. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days prior to dosing. Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases. Patients with history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with an ejection fraction under 40%. Patients currently receiving chemotherapy or radiation therapy. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication Patients deemed otherwise clinically unfit for clinical trial per investigators discretion
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer Klein, MEd
    Phone
    2158540770
    Email
    jklein@gog.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bradley Corr, MD
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Letrozole in Uterine Leiomyosarcoma

    We'll reach out to this number within 24 hrs