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Clinical Trials in Ireland / NCT04095364
Active, not recruiting Phase 3

Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT04095364 · tracked via the Priya Life Science Ireland tracker
Sponsor
NRG Oncology
Phase
Phase 3
Started
2019-09-20
Last updated
2026-03-24

Condition(s) studied

Low Grade Fallopian Tube Serous AdenocarcinomaOvarian Low Grade Serous AdenocarcinomaPrimary Peritoneal Low Grade Serous AdenocarcinomaStage II Fallopian Tube Cancer AJCC v8Stage II Ovarian Cancer AJCC v8Stage II Primary Peritoneal Cancer AJCC v8Stage III Fallopian Tube Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Primary Peritoneal Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8

Investigational drug(s) / intervention(s)

Biopsy ProcedureBiospecimen CollectionCarboplatinImaging ProcedureLetrozolePaclitaxel

Biopsy Procedure: Undergo tumor biopsy

Biospecimen Collection: Undergo blood sample collection

Carboplatin: Given IV

Imaging Procedure: Undergo medical imaging

Letrozole: Given PO

Paclitaxel: Given IV

Study summary

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Patients must have newly diagnosed, stage II-IV low-grade serous ovarian cancer (submission of pathology report\[s\] required). Ovarian cancer = ovarian, fallopian tube and primary peritoneal cancers * NOTE: Patients with a prior history of serous borderline tumors but a new diagnosis of stage II-IV low-grade serous ovarian cancer are eligible * p53 immunohistochemistry (IHC) is required and must show nonaberrant pattern (nonaberrant p53 expression is consistent with normal/wildtype TP53) * A copy of the pathology report that includes the diagnosis of low grade serous ovarian cancer and nonaberrant p53 IHC result must be submitted in RAVE. NOTE: If aberrant p53 expression is found on p53 IHC, the patient is NOT eligible (aberrant p53 expression is consistent with mutant TP53 and supports diagnosis of high grade serous ovarian cancer) * Appropriate stage for study entry based on the following diagnostic workup: * History/physical examination within 14 days prior to registration; * Radiographic tumor assessment within 28 days prior to registration. (23-MAY-2023) * Age \>= 18 * Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (=\< 1 cm diameter residual disease/nodule) or suboptimal residual disease (\> 1 cm diameter residual disease/nodule) status allowed * Patients must have undergone a bilateral salpingo-oophorectomy * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to registration * Patients must be within =\< 8 weeks of primary cytoreductive surgery at time of randomization * Patients must be able to take per oral (P.O.) medications * Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl (within 14 days prior to registration) * Platelets greater than or equal to 100,000 cells/mcl (within 14 days prior to registration) * Creatinine less than or equal to 1.5 x upper limit of normal (ULN) (within 14 days prior to registration) * Bilirubin less than or equal to 1.5 x ULN (within 14 days prior to registration) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 x ULN (within 14 days prior to registration) * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Exclusion Criteria: * Patients may not have received neoadjuvant or adjuvant chemotherapy or radiotherapy for the treatment of this disease * Patients may not have received previous hormonal therapy for the treatment of this disease * Patients with known hypersensitivity to letrozole or hypersensitivity/intolerance to carboplatin/paclitaxel therapy * Patients with severe cardiac disease: * Myocardial infarction or unstable angina within 6 months prior to registration * New York Heart Association (NYHA) class II or greater congestive heart failure * Patients with known central nervous system metastases * Patients with active (except for uncomplicated urinary tract infection) or uncontrolled systemic infection * Patients with \>= grade 2 baseline neuropathy * Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Primary outcome measure(s)

Trial sites (909)

FacilityCityRegionStatus
Anchorage Associates in Radiation Medicine Anchorage Alaska
Anchorage Radiation Therapy Center Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
CTCA at Western Regional Medical Center Goodyear Arizona
Kingman Regional Medical Center Kingman Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
Mercy Hospital Fort Smith Fort Smith Arkansas
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
CARTI Cancer Center Little Rock Arkansas
University of Arkansas for Medical Sciences Little Rock Arkansas
Kaiser Permanente-Deer Valley Medical Center Antioch California
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
PCR Oncology Arroyo Grande California
Sutter Auburn Faith Hospital Auburn California
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
Kaiser Permanente-Bellflower Bellflower California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Keck Medicine of USC Buena Park Buena Park California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Mills-Peninsula Medical Center Burlingame California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
Mercy Cancer Center - Carmichael Carmichael California
Mercy San Juan Medical Center Carmichael California
Eden Hospital Medical Center Castro Valley California
Community Cancer Institute Clovis California
University Oncology Associates Clovis California
Sutter Davis Hospital Davis California
City of Hope Comprehensive Cancer Center Duarte California
Kaiser Permanente Dublin Dublin California
Mercy Cancer Center - Elk Grove Elk Grove California

+ 869 more sites — see the full list on the official registry below.

More NRG Oncology trials in Ireland

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04095364 on ClinicalTrials.gov ↗ ← All trials in Ireland