- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649956
Letrozole in Uterine Leiomyosarcoma
A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jennifer Klein, MEd
- Phone Number: 2158540770
- Email: jklein@gog.org
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- Recruiting
- Women's Cancer Center of Nevada
-
Contact:
- Jacky Amador
- Email: Jamador@wccenter.com
-
Principal Investigator:
- Nicola Spirtos, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Observation
|
|
Experimental: Letrozole
Letrozole 2.5 mg orally
|
Letrozole 2.5 mg PO daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival
Time Frame: Measured from time of enrollment until date of progression or death up 3 years from randomization
|
Measured from time of enrollment until date of progression or death up 3 years from randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: Measured for time of enrollment to time of death assessed up to 5 years from randomization
|
Measured for time of enrollment to time of death assessed up to 5 years from randomization
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Bradley Corr, MD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Neoplasms, Muscle Tissue
- Leiomyosarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
Other Study ID Numbers
- GOG-3088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uterine Leiomyosarcoma
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Leiomyosarcoma | Stage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Unresectable Leiomyosarcoma | Stage IIIA Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IIIC Uterine Corpus Leiomyosarcoma... and other conditionsUnited States
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National Cancer Institute (NCI)RecruitingLocally Advanced Uterine Corpus Leiomyosarcoma | Metastatic Uterine Corpus Leiomyosarcoma | Stage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Unresectable Uterine Corpus LeiomyosarcomaUnited States, Puerto Rico
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingLocally Advanced Leiomyosarcoma | Metastatic Leiomyosarcoma | Stage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Unresectable Leiomyosarcoma | Uterine Corpus LeiomyosarcomaUnited States
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National Cancer Institute (NCI)Active, not recruitingStage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Uterine Corpus LeiomyosarcomaUnited States
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National Cancer Institute (NCI)Active, not recruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Uterine Corpus LeiomyosarcomaUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage I Uterine Sarcoma AJCC v7United States, Belgium, France, Spain, United Kingdom, Netherlands, Norway, Venezuela
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National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedRecurrent Uterine Sarcoma | Uterine LeiomyosarcomaUnited States
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National Cancer Institute (NCI)TerminatedHigh Grade Sarcoma | Metastatic Leiomyosarcoma | Stage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Unresectable Leiomyosarcoma | Myxofibrosarcoma | Metastatic Malignant Peripheral Nerve Sheath Tumor | Metastatic Synovial Sarcoma | Metastatic Undifferentiated... and other conditionsUnited States
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