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
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
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.
More NRG Oncology trials in Ireland