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
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)
Progression-free survival (PFS) — Time from the randomized treatment assignment to documentation of disease progression (Response Evaluation Criteria in Solid Tumors 1.1) or death from any cause, whichever comes first, assessed up to 8 years The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status. Estimates for the letrozole/letrozole (L/L) vs paclitaxel/carboplatin/letrozole (CT/L) hazard ratio and its confidence interval will be obtained using a stratified Cox proportional hazards model. Potential confounding factors, including the stratification factors, performance status and self-declared racial designation will be considered in a final exploratory model. A forest plot of treatment hazard ratios with confidence intervals within subgroups will also be reported. PFS will be characterized by treatment group with Kaplan-Meier plots and estimates of the median PFS.
Trial sites (909)
Facility
City
Region
Status
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.
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.
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