Status:
ACTIVE_NOT_RECRUITING
Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Lead Sponsor:
NRG Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Low Grade Fallopian Tube Serous Adenocarcinoma
Ovarian Low Grade Serous Adenocarcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 perit...
Detailed Description
PRIMARY OBJECTIVE: I. To examine if letrozole monotherapy/maintenance (L/L) is non-inferior to intravenous (IV) paclitaxel/carboplatin and maintenance letrozole (CT/L) with respect to progression-fre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04095364
Start Date
September 20 2019
End Date
February 1 2028
Last Update
October 8 2025
Active Locations (911)
Enter a location and click search to find clinical trials sorted by distance.
1
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States, 98508
2
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States, 99504
3
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508
4
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508