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

L
Lisa Landrum, MD, PhD, MS

Primary Investigator

Enrolling By Invitation
18 years and older
Female
Phase 3
450 participants needed
3 Locations

Brief description of study

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,ube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount ofgen made by the body which in turn may stop the growth of tumor cells that need estrogengrow. 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 letrozolebination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared tod carboplatin without letrozole.

Detailed description of study

PRIMARY OBJECTIVE:
I. To examine if letrozole monotherapy/maintenance (L/L) is non-inferior to intravenous (IV)/carboplatin and maintenance letrozole (CT/L) with respect to progression-freeurvival (PFS) in women with stage II-IV primary low-grade serous carcinoma of the ovary orum after primary surgical cytoreduction.
SECONDARY OBJECTIVES:
I. To compare the nature, frequency and maximum degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 for each treatment arm.
II. To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm.
III. To compare overall survival for each treatment arm. IV. To compare the CT/L and L/L arms with respect to patients' adherence to letrozole therapy as measured by pill counts.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Cycles repeatvery 21 days for up to 6 cycles. Patients then receive letrozole orally (PO) once daily (QD)he absence of disease progression or unacceptable toxicity.
ARM II: Patients receive letrozole PO QD in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,very 6 months for 3 years, then annually thereafter.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Low Grade Fallopian Tube Serous Adenocarcinoma, Ovarian Low Grade Serous Adenocarcinoma, Primary Peritoneal Low Grade Serous Adenocarcinoma, Stage II Fallopian Tube Cancer AJCC v8, Stage II Ovarian Cancer AJCC v8, Stage II Primary Peritoneal Cancer AJCC v8, Stage IIA Fallopian Tube Cancer AJCC v8, Stage IIA Ovarian Cancer AJCC v8, Stage IIA Primary Peritoneal Cancer AJCC v8, Stage IIB Fallopian Tube Cancer AJCC v8, Stage IIB Ovarian Cancer AJCC v8, Stage IIB Primary Peritoneal Cancer AJCC v8, Stage III Fallopian Tube Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage III Primary Peritoneal Cancer AJCC v8, Stage IIIA Fallopian Tube Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8, Stage IIIA Primary Peritoneal Cancer AJCC v8, Stage IIIA1 Fallopian Tube Cancer AJCC v8, Stage IIIA1 Ovarian Cancer AJCC v8, Stage IIIA2 Fallopian Tube Cancer AJCC v8, Stage IIIA2 Ovarian Cancer AJCC v8, Stage IIIB Fallopian Tube Cancer AJCC v8, Stage IIIB Ovarian Cancer AJCC v8, Stage IIIB Primary Peritoneal Cancer AJCC v8, Stage IIIC Fallopian Tube Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IIIC Primary Peritoneal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Primary Peritoneal Cancer AJCC v8, Stage IVA Fallopian Tube Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVA Primary Peritoneal Cancer AJCC v8, Stage IVB Fallopian Tube Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Stage IVB Primary Peritoneal Cancer AJCC v8
  • Age: 18 Years
  • Gender: Female

Inclusion Criteria:
  • Patients must have the psychological ability and general health that permitshe study requirements and required follow up
  • All women will, by definition, be considered menopausal due to surgical removal ofboth ovaries prior to trial enrollment
  • Patients must have newly diagnosed, stage II-IV low-grade serous ovarian cancer(submission of pathology report[s] required). Ovarian cancer = ovarian, fallopian tubed primary peritoneal cancers. p53 immunohistochemistry (IHC) is required and musthow nonaberrant pattern (nonaberrant p53 expression is consistent with/wildtype TP53). If aberrant p53 expression is found on p53 IHC, the patient isT eligible (aberrant p53 expression is consistent with mutant TP53 and supportsdiagnosis of high grade serous ovarian cancer). A copy of the pathology report thatudes the diagnosis of low grade serous ovarian cancer and nonaberrant p53 IHCult must be submitted in RAVE
  • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 14 days prior to registration
    • Contrast-enhanced imaging of the chest, abdomen and pelvis within 28 days priorgistration
  • Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with
    either optimal (=< 1 cm diameter residual disease/nodule) or suboptimal residualdisease (> 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 of1 or 2 within 14 days prior to registration
  • Patients must be within =< 8 weeks of primary cytoreductive surgery at time ofdomization
  • 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 daysgistration)
  • Platelets greater than or equal to 100,000 cells/mcl (within 14 days prior togistration)
  • Creatinine less than or equal to 1.5 x upper limit of normal (ULN) (within 14 daysgistration)
  • 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 equal3 x ULN (within 14 days prior to registration)
  • The patient or a legally authorized representative must provide study-specificd consent prior to study entry and, for patients treated in the United States(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
  • Patients with a prior or concurrent malignancy whose natural history or treatment doeshave the potential to interfere with the safety or efficacy assessment of thevestigational regimen are eligible for this trial
  • Patients may not have received neoadjuvant chemotherapy or radiotherapy for thehis disease
  • Patients may not have received previous hormonal therapy for the treatment of thisdisease
  • Patients with known hypersensitivity to letrozole or hypersensitivity/intolerance toboplatin/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) oruncontrolled systemic infection
  • Patients with >= grade 2 baseline neuropathy
  • Known human immunodeficiency virus (HIV)-infected patients on effectiveviral therapy with undetectable viral load within 6 months are eligible forhis trial

Updated on 01 Aug 2024. Study ID: NRG-GY019
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