Letrozole in Uterine Leiomyosarcoma

NCT05649956 | Recruiting Phase 2 FDA Drug

• 1 other identifier: GOG-3088
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 25

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.

Conditions

Uterine Leiomyosarcoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Measured from time of enrollment until date of progression or death up 3 years from randomization

Study Arms (2)

Letrozole

EXPERIMENTAL

Letrozole 2.5 mg orally

Drug: Letrozole

Observation

NO INTERVENTION

Observation

Interventions

Letrozole DRUG

Letrozole 2.5 mg PO daily

Letrozole

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.
• Patient must have histologically confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus (FIGO 2009 Stage I). Submission of pathology report documenting uterine leiomyosarcoma histology is required in the IRT Source Document Portal following randomization.
• Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemistry). ER status test results must be provided at enrollment. Sites are required to report results of ER status testing in the IRT Source Document Portal.
• Patient must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from enrollment.
• All patients must have NO measurable disease as defined by RECIST 1.1 within 6 weeks of enrollment. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI.
• Patients must have an ECOG performance status of 0, 1, or 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 cells/mcl
• Platelet count greater than or equal to 100,000 cells/mcl
• Hemoglobin greater than or equal to 9.0 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:
• Serum creatinine less than or equal to 1.5 x ULN
• Hepatic function:

You may not qualify if:

• \. 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 concomitant invasive malignancy or a history of prior malignancy except non-melanoma skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.
• \. Patients who have a history of taking any aromatase inhibitor within the past 5 years.
• \. Patients with active or uncontrolled systemic infection. 6. Patients with history of uncontrolled cardiac disease, i.e., uncontrolled hypertension (defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm HR despite antihypertensive medications), unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure (NYHA Class II or greater), clinically significant cardiac arrhythmias, and cardiomyopathy with an ejection fraction under 40%.
• \. Patients currently receiving chemotherapy or radiation therapy. 8. Patients with severe hepatic impairment and/or cirrhosis. 9. 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.
• \. Patients with known hypersensitivity to any of the excipients of letrozole. 12. Patients who are pregnant or breast-feeding. 13. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days of prior to enrollment.
• \. Patients currently using systemic estrogens, including herbals and supplements with estrogenic properties. The use of vaginal estrogen is permitted if symptoms are refractory to moisturizers and lubricants.

Sponsors & Collaborators

• GOG Foundation: lead

Study Sites (25)

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

RECRUITING

Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States

RECRUITING

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

RECRUITING

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

RECRUITING

Winship Cancer Institute, Emory Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Endeavor Health - Kellogg Cancer Center

Evanston, Illinois, 60201, United States

RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

RECRUITING

WK Physician Network-Gynecologic Oncology Associates

Shreveport, Louisiana, 71103, United States

RECRUITING

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89106, United States

RECRUITING

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89511, United States

RECRUITING

Atlantic Health System

Morristown, New Jersey, 07960, United States

RECRUITING

Overlook Medical Center

Summit, New Jersey, 07901, United States

RECRUITING

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131, United States

RECRUITING

East Carolina University Health Medical Center

Greenville, North Carolina, 27834, United States

RECRUITING

OhioHealth Arthur G.H. Bing, MD Cancer Center

Columbus, Ohio, 43214, United States

RECRUITING

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

RECRUITING

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

RECRUITING

OhioHealth Grant Medical Center

Columbus, Ohio, 43215, United States

RECRUITING

OhioHealth Marion General Hospital

Marion, Ohio, 43302, United States

RECRUITING

University of Oklahoma Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

RECRUITING

Woman and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

RECRUITING

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bradley Corr, MD

  University of Colorado, Denver

  STUDY CHAIR

Central Study Contacts

Sarin Chhab

CONTACT

2158540770; schhab@gog.org

Shanon Matkin

CONTACT

smatkin@gog.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: July 17, 2024
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)